Z-0101-2023 Class II Ongoing
FDA device recall Z-0101-2023 was initiated by Synthes (USA) Products LLC on Sep 27, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 196.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 26, 2022
- Initiation Date
- Sep 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196
Product Description
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0101-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026