CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report

Vl Dbl Offst WI Lrg Stpl, RT Nonsterile recalled by Zimmer

Zimmer is recalling Vl Dbl Offst WI Lrg Stpl, RT Nonsterile, distributed nationwide in the US. The recall was initiated on 23 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585

Quantity recalled412 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-2223-2014
FDA event ID: 68656
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2014
FDA classified: 14 Aug 2014
Reported: 20 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

23 Jul 2014	Recall initiated by company
14 Aug 2014	Classified by FDA	+22 days
20 Aug 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

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

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

Vl DBL OFFST WI LRG STPL, RT Nonsterile

Where it was distributed

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

Nationwide Alaska Alabama Arizona California Colorado Florida Georgia Indiana Kansas Kentucky Michigan Minnesota North Carolina New Jersey New York Ohio Oklahoma Oregon Pennsylvania South Dakota

Questions about this recall

Is Vl Dbl Offst WI Lrg Stpl, RT Nonsterile recalled?

Yes. Zimmer recalled Vl Dbl Offst WI Lrg Stpl, RT Nonsterile on 23 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2223-2014.

Why was it recalled?

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Which lots are affected?

Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585

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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