FDA Enforcement
Class II
Terminated
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Recall: Z-2242-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2242-2021
- Event ID
- 88311
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smith & Nephew Orthopaedics Ltd. (Aurora)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 18, 2021
- Initiation Date
- July 14, 2021
- Classification Date
- August 11, 2021
- Termination Date
- May 13, 2024
- Address
- Aurora, Spa Park, Harrison Way, Leamington Spa, N/A, N/A, United Kingdom
Description
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Reason
The nail head may become detached during surgery.
Code Info
Lot/Batch Codes: 20LW15962, 20LW15963
Distribution
Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.
Quantity
47 units