Stryker Spine Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430.
Brand
Stryker Spine
Lot Codes / Batch Numbers
All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm, 48650114m size 14 mm, 48650116, 16 mm, 48650118, size 18mm, 48650120, size 20 mm, 48650122, size 22 mm. 48650224, Reflex Hybrid Two-Level Plate, size 24 mm, 48650226, size 26 mm, 48650228, size 28 mm, 48650230, size 30 mm, 48650232, size 32 mm, 48650234, size 34 mm, 48650237, size 37 mm, 48650240, size 40 mm, 48650243, size 43 mm, 48650246, size 46 mm. 48650339, REflex Hybrid Three-Level Plate, Size 39 mm, 48650342, size 42mm, 48650345, suze 45 mm, 48650348, size 48 mm, 48650351, size 51 mm, 48650354, size 54 mm, 48650357, size 57 mm, 48650360, size 60 mm, 48650363, size 63 mm, 48650366, size 66 mm, 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm, 48650464, size 64 mm, 48650468, size 68 mm, 48650472, size 72 mm, 48650476, size 76 mm, 48650489, size 80 mm, 48650484, size 84 mm.
Products Sold
All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm. 48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, REflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, suze 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm.
Stryker Spine is recalling Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, due to Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
Recommended Action
Per FDA guidance
Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.
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