CLASS II Device recall · Reported 26 Sep 2012 · FDA Enforcement Report

12/14 Taper High Offset Neck Use With Smith & Nephew Stems recalled

Smith & Nephew is recalling 12/14 Taper High Offset Neck Use With Smith & Nephew Stems And 12/14 Femoral Components, distributed nationwide in the US. The recall was initiated on 22 Aug 2012 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled70 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2427-2012
FDA event ID: 63089
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2012
FDA classified: 20 Sep 2012
Reported: 26 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Hip & Knee Implants

Timeline

22 Aug 2012	Recall initiated by company
20 Sep 2012	Classified by FDA	+29 days
26 Sep 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Florida Georgia Illinois Indiana Massachusetts North Carolina New Jersey New York Ohio Oklahoma Pennsylvania Tennessee Texas Washington

Questions about this recall

Is 12/14 Taper High Offset Neck Use With Smith & Nephew Stems And 12/14 Femoral Components recalled?

Yes. Smith & Nephew recalled 12/14 Taper High Offset Neck Use With Smith & Nephew Stems And 12/14 Femoral Components on 22 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-2427-2012.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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