Z-2427-2012Class II

12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF...

Name: Z-2427-2012 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF...
Creator: Smith & Nephew Inc
Published: 2012-08-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2012-08-22 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA... on 2012-08-22. FDA classified it as Class II and gives the reason as "Modular necks were manufactured out of specification by a vendor; the taper provide is undersized". 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-2427-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-22
Posted: 2012-09-20
Terminated: 2013-02-27
Recalling firm: Smith & Nephew, Inc.
Product: 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Smith & Nephew sent an "URGENT:CLASS II RECALL-HIGH OFFSET MODULAR NECK R1213 letter dated August 22, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to cease use and distribution of the product and quarantine for return. An Inventory Return Certification Form was included for customers to complete and return via fax to 901-566-7975.
Quantity in commerce: 70 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.
Product codes and lots: Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2427-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2427-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code MEH

K081124Class IIMdf Revision Hip SystemSmith & Nephew, Inc. / cleared 2008-07-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)