SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Company
- Synthes (Usa) Products Llc
- Recall Initiated
- September 27, 2022
- Posted
- October 18, 2022
- Recall Number
- Z-0099-2023
- Quantity
- 94 US; 30 OUS
- Firm Location
- West Chester, PA
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Root Cause
Error in labeling
Action Taken
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.