Reported Sep 4, 2013 · Terminated
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8…
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. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
- Lot codes and dates
1,042 of 1,042 codes
605501466058523460585240606213586061282260585235606128246058523960629949606299516057315760612823606128326062994860629756606297556062995060560744606213466062134760621348606213506061282660621349606213516062135360585244606128206061283060621354606213566062135760612825606128296061283160653083606530926065307560653078606530856065308860653100606531116053940860539409606530956065309860653107606531106065311460653116606531156065312160671979606719806065314660671982605611436065310860653109
- Amount recalled
- 85, 794 units in total
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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