Reported Sep 4, 2013 · Terminated
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3,…
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?
- Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.
- Lot codes and dates
346 of 346 codes
606110496062452060619105606191096062451860624519606255446061910760619879606110456062452160625511606255366062554260582204606198876065704760646266606570466065707060657071606570726063272560657051606570736065708360657075606570786065708860625545606462676065704960657052606570776065707960657087606570846066830460668305605820896067443060674431606851156071488660714872607148936071487560714897607148516071489060714892607148506071487760714896607148916071489460763218607632326076321960763220
- 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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