Z-0008-2023 Class II Ongoing
FDA device recall Z-0008-2023 was initiated by Synthes (USA) Products LLC on Aug 30, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 191 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2022
- Initiation Date
- Aug 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 units
Product Description
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
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0008-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026