Z-0401-2022 Class II Ongoing
FDA device recall Z-0401-2022 was initiated by Wright Medical Technology, Inc. on Dec 3, 2021 and is designated Class II. Reason for recall: Incorrect product is contained in the packaging. The recall status is ongoing. Affected quantity: 22 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 29, 2021
- Initiation Date
- Dec 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product Description
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Reason for Recall
Incorrect product is contained in the packaging.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.
Code Information
Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0401-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026