CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report

Cpt Degree Taper (various sizes) and Femoral HD (various sizes) recalled

Zimmer is recalling Cpt Degree Taper (various sizes) and Femoral HD (various sizes), distributed nationwide in the US. The recall was initiated on 11 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes60275282 60089260 60145841 60147718 60156456 60089259 60156459 60200116 62135079 62079190 60732916 60638837 62094973 61887194 60457227

Quantity recalled7,044,680 total

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-1036-2014
FDA event ID: 66500
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 11 Oct 2013
FDA classified: 20 Feb 2014
Reported: 26 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

11 Oct 2013	Recall initiated by company
20 Feb 2014	Classified by FDA	+132 days
26 Feb 2014	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

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

Nationwide

Questions about this recall

Is Cpt Degree Taper (various sizes) and Femoral HD (various sizes) recalled?

Yes. Zimmer recalled Cpt Degree Taper (various sizes) and Femoral HD (various sizes) on 11 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-1036-2014.

Why was it recalled?

Which lots are affected?

60275282 60089260 60145841 60147718 60156456 60089259 60156459 60200116 62135079 62079190 60732916 60638837 62094973 61887194 60457227

Where was it sold?

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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