Z-0101-2023 Class II Ongoing
FDA device recall Z-0101-2023 was initiated by Synthes (USA) Products LLC on September 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 inco… The recall status is ongoing. Affected quantity: 196.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- September 27, 2022
- Termination Date
- N/A
- 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