Leamington Spa, N/A, United Kingdom
Smith & Nephew Orthopaedics Ltd. (Aurora) recalls
1 recall recorded since 2018, most recently on 14 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 July 2021
- Terminated
- 13 May 2024
- Reason
- The nail head may become detached during surgery.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2242-2021
- smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.