Recall Z-0101-2023
Synthes (USA) Products LLC · initiated September 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Codes / lots: UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027
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.
FDA-determined 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.
Details
- Recall number
- Z-0101-2023
- Initiated
- September 27, 2022
- Posted by FDA
- October 18, 2022
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 196
- Distribution
- US Nationwide distribution.
- Recalling firm
- Synthes (USA) Products LLC, West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0098-2023 Class II | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with…The subject products are being recalled because they contain the incorrect size drill guide and will not… | 09/27/2022Open, Classified |
| Z-0099-2023 Class II | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512The subject products are being recalled because they contain the incorrect size drill guide and will not… | 09/27/2022Open, Classified |
| Z-0100-2023 Class II | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910The subject products are being recalled because they contain the incorrect size drill guide and will not… | 09/27/2022Open, Classified |