FDA recall Z-2242-2021

Smith & Nephew Orthopaedics Ltd. (Aurora) · Class II · device

Product

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

Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.

Key facts

Status
Terminated
Initiation date
2021-07-14
Report date
2021-08-18
Termination date
2024-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Leamington Spa, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2242-2021