Reported Jul 2, 2014 · Terminated

VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

Zimmer, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

  • VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Lot codes and dates

9 of 9 products

Products covered by this recall
Model / numberProduct as published
784301108Lot #'s: 62478967, 62479742, 62503408, 62528282, 62530786, 62544915, 62554360
784301156Item # 784301126, Lot #: 62544885, 62547211, , Lot #, 62587079
784301208Lot #'s: 62503411, 62509385, 62530790, 62547217, 62554362
784301226Lot #'s: 62515502, 62547216
784301256Lot #'s: 62489572, 62522386
784301326Lot #, 62496464, 62594428, 62622893
784301356Lot #: 62622894
784301382Lot #: 62544907
784301581Item # 784301511, Lot #: 62472423 & , Lot #: 62496469.
Amount recalled
147 units

Where it was sold

Why it was recalled

During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 24, 2015 · Data as of Sep 19, 6:52 PM UTC

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