Z-2745-2015Class II

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38...

Name: Z-2745-2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38...
Creator: Smith & Nephew, Inc.
Published: 2015-06-03
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2015-06-03 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144... on 2015-06-03. FDA classified it as Class II and gives the reason as "The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2745-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-09-10
Terminated: 2017-01-21
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
Product code: NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Reason for recall: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Root cause tag: design
FDA root cause: Device Design
Action: Smith & Nephew sent an notification letter dated June 3, 2015 to customers via E-mail and Fed- Ex. The letter identified the affected product, problem and actions to be taken. Customers were asked to quarantine the product and return it. Distributors were asked to notified their customers of the recall and ask them to return the product.
Quantity in commerce: 5,987 units
Distribution: Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2745-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2745-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-09
Z-2746-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-09
Z-2747-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-09

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)