Z-2242-2021 Class II Terminated
FDA device recall Z-2242-2021 was initiated by Smith & Nephew Orthopaedics Ltd. (Aurora) on July 14, 2021 and is designated Class II. Reason for recall: The nail head may become detached during surgery. The recall status is terminated (terminated May 13, 2024). Affected quantity: 47 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 14, 2021
- Termination Date
- May 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
Product Description
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Reason for Recall
The nail head may become detached during surgery.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.
Code Information
Lot/Batch Codes: 20LW15962, 20LW15963