Hammertoe Continuous Compression Implant — Class II medical device recall Z-0008-2023
Ongoing recall by Synthes (USA) Products LLC, reported 2022-10-12, distributed nationwide. Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error,
| Recall number | Z-0008-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2022-08-30 |
| Classified | 2022-10-06 |
| Reported by FDA | 2022-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 191 units |
| UPC / GTIN / UDI-DI | 00810633022047 |
| Lot numbers | MHC220119, MHC220120 |
| Model numbers | 46.239.001 |
| Expiration dates | 2027-06-01 |
Product
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Reason for recall
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0008-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.