Z-2267-2018Class II

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156

Name: Z-2267-2018 Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Creator: Smith & Nephew, Inc.
Published: 2018-05-11
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-05-11 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156 on 2018-05-11. FDA classified it as Class II and gives the reason as "The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2267-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Posted: 2018-05-21
Terminated: 2019-04-05
Recalling firm: Smith & Nephew, Inc.
Product: Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Product code: NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Reason for recall: The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.
Quantity in commerce: 2 units
Distribution: OH, TX, CO, TN, MI, PA, NJ
Product codes and lots: (a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2267-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2267-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-21
Z-2268-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-21

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)