Reported Apr 26, 2017 · Terminated
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap…
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. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc
- Neutral Max-Rom E1 Liner Product UsageFor use in hip arthroplasty
- Lot codes and dates
76 of 76 products
Products covered by this recall Model / number Product as published 11-105900712480 11-105901695030 695040 11-105902309540 605110 605120 605130 712810 712830 712850 712860 11-105911577890 11-105912577920 11-105913577930 11-105933577950 11-165208779480 797810 11-165216905190 11-165220905230 11-165222808510 905270 920560 11-165224905130 11-165226758530 758550 797970 920600 11-165228879860 11-165232716050 732560 732580 920670 11-165236896290 11-165240779430 12-105994272230 CP162598354160 EP-105833371770 - Amount recalled
- 28,253 in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
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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