Z-0393-2022 Class II Ongoing
FDA device recall Z-0393-2022 was initiated by Wright Medical Technology Inc on Dec 3, 2021 and is designated Class II. Reason for recall: The incorrect product is contained in the packaging. The recall status is ongoing. Affected quantity: 250 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 29, 2021
- Initiation Date
- Dec 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 units
Product Description
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Reason for Recall
The incorrect product is contained in the packaging.
Distribution Pattern
Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
Code Information
Lot #1643355
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0393-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026