FDA Device recall Z-0008-2023
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
- FDA Device
- Class II
- ongoing
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class II recall of Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 by Synthes Usa Products, citing 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 larg….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0008-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-30 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Reason
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
Identifiers
| code_info | UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2023%22
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