Z-2242-2021Class II

smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery

Name: Z-2242-2021 smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery
Creator: Smith & Nephew Orthopaedics Ltd. (Aurora)
Published: 2021-07-14
License: https://open.fda.gov/license/

Smith & Nephew Orthopaedics Ltd. (Aurora) / initiated 2021-07-14 / Terminated

FDA source

Smith & Nephew Orthopaedics Ltd. (Aurora) began a recall of smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery on 2021-07-14. FDA classified it as Class II and gives the reason as "The nail head may become detached during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2242-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-14
Posted: 2021-08-11
Terminated: 2024-05-13
Recalling firm: Smith & Nephew Orthopaedics Ltd. (Aurora)
Product: smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Product code: NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Reason for recall: The nail head may become detached during surgery.
FDA 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 in commerce: 47 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.
Product codes and lots: Lot/Batch Codes: 20LW15962, 20LW15963

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2242-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2242-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-11

Product code NXT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)