Smith & Nephew Inc: Medical Device Recall in 2012 - (Recall #: Z-2427-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 22, 2012

Date Posted: September 26, 2012

Recall Number: Z-2427-2012

Event ID: 63089

Reason for Recall:

Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

Status: Terminated

Product Quantity: 70 units

Code Information:

Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated