DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
FDA device recall Z-0101-2023 · posted 2022-10-18 · Open, Classified
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- JDR
- Quantity affected
- 196
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-09-27
- Date posted
- 2022-10-18
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DePuy Synthes Hammertoe Continuous Compression Implant (K191463) | Synthes (USA) Products, LLC | 2020-02-26 |