Z-0143-2022 Class II Terminated
FDA device recall Z-0143-2022 was initiated by Smith & Nephew, Inc. on September 20, 2021 and is designated Class II. Reason for recall: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. The recall status is terminated (terminated March 24, 2023). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 20, 2021
- Termination Date
- March 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
6.5MMX165MM CANNULATED SCREW
Reason for Recall
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
Code Information
Model 71106365S; Lot 20GT39417