FDA Medical Device Recalls (openFDA)
Smith & Nephew Orthopaedics Ltd. (Aurora): smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
- Recall number
- Z-2242-2021
- Recalling firm
- Smith & Nephew Orthopaedics Ltd. (Aurora)
- Product
- smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
- Status
- Terminated
- Initiated
- 2021-07-14
- Posted
- not on file
- Terminated
- 2024-05-13
- Reason
- The nail head may become detached during surgery.
- Root cause
- Component change control
- Action
- The firm notified its consignee by letter on 07/14/2021. The letter explained the issue and the hazard and requested the return of the products.
- Quantity
- 47 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.
- Lot, serial or model codes
- Lot/Batch Codes: 20LW15962, 20LW15963
- 510(k) numbers
- not on file
- PMA numbers
- ["P040033"]
- Product code
- NXT
- Firm FEI
- 3005975929
- Firm city
- Leamington Spa
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28