FDA Device recall Z-0101-2023
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 by Synthes Usa Products, citing 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 ste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0101-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-27 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Reason
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.
Identifiers
| code_info | UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Synthes Usa Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0101-2023%22
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