Synthes (USA) Products LLC SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Brand
Synthes (USA) Products LLC
Lot Codes / Batch Numbers
UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Products Sold
UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Synthes (USA) Products LLC is recalling SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 due to The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Recommended Action
Per FDA guidance
On September 27, 2022, the firm notified affected customers via urgent medical Device Recall letters. Customers were instructed to examine their inventory to determine if they have affected product and to quarantine them immediately - Customers should not use the recalled products. Customers should contact their DePuy Synthes Sales Consultant or call the customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products.
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