Reported Mar 2, 2016 · Terminated
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated,…
Zimmer Biomet, 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 Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
- Lot codes and dates
- Item numbers
00-5926-011-0100-5926-011-0200-5926-012-0100-5926-012-0200-5926-013-0100-5926-013-0200-5926-014-0100-5926-014-0200-5926-015-0100-5926-015-02
- Lot numbers
532 of 532 codes
110033851100348711003827110039571100405511004100110041021100410611004145110043781100444411004449110044541100446411004499110057121100577911005783110060581100662311006851110068781100692511006973110082451100825911008270110083311100838161771793617717956177745361777454617774556177745661777457617826366178263761782638617826396178264061782641617826426178882161788822617888236178882461788825617888266178882761795693617956946179569561795696617956976179569861801039618010406180104161801042
- Item numbers
- Amount recalled
- 5103
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- FL
Why it was recalled
LDPE bag containing the implant adheres to the highly polished implant surface.
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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