Synthes (USA) Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
Brand
Synthes (USA)
Lot Codes / Batch Numbers
Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009, 1.5MM resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009, 1.5MM resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009, 1.5MM resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009, 1.5MM resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009, 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009, 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1387942, 09/2009, 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751, 07/2009, 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122, 07/2009, 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368, 10/2009, 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323, 02/2010, 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135, 07/2009, 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578, 8/2009, 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602, 08/2009, 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219, 09/2009, 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401, 07/2009, 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216, 08/2009, 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498, 08/2009, 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.20S, 1372402, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297, 12/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984, 02/2010, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384599, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392088, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2162401, 10/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458, 10/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459, 10/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282, 10/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890, 10/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2169299, 12/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554, 01/2010, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801, 01/2010, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370041, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377502, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385780, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393234, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039, 07/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1383881, 08/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089, 09/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288, 11/2009, 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842, 02/2010, 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1384604, 08/2009, 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091, 09/2009, 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289, 11/2009, 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134, 07/2009, 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551, 01/2010, 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 1393239, 09/2009, 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849, 02/2010, 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288, 10/2010, 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641, 07/2009, 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291, 11/2009, 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.02S, 2171103, 12/2009, 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552, 01/2010, 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009, 1.5MM rapid resorbable tack 4MM-sterile, 805.614.10S, 2165696, 11/2009, 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009, 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009, 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009, 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009, 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.02S, 2167290, 11/2009, 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009, 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009, 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009, 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009, 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.10S, 1374136, 07/2009, 2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093, 09/2009, 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009.
Products Sold
Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1387942, 09/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751, 07/2009; 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122, 07/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368, 10/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323, 02/2010; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135, 07/2009; 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578, 8/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219, 09/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401, 07/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.20S, 1372402, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984, 02/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384599, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392088, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2162401, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2169299, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370041, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377502, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385780, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393234, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1383881, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288, 11/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842, 02/2010; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1384604, 08/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091, 09/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289, 11/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134, 07/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551, 01/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 1393239, 09/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849, 02/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288, 10/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641, 07/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291, 11/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.02S, 2171103, 12/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552, 01/2010; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.10S, 2165696, 11/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.02S, 2167290, 11/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.10S, 1374136, 07/2009; 2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093, 09/2009; 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009.
Synthes (USA) is recalling Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair due to Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
Recommended Action
Per FDA guidance
Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026