Reported Apr 26, 2017 · Terminated
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder…
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 Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive
- Reverse Shoulder System Product UsageShoulder Replacement Elbow Replacement
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published 113870361800 113951605610 684300 684310 684320 684330 684340 113952174480 241520 292440 292480 372590 372600 372610 372620 372630 372640 596930 596940 596950 596960 605640 605650 605670 113954174560 241500 270220 270230 292490 292510 292520 292560 292570 372650 372660 372670 372680 372700 372710 596970 596980 596990 605680 605690 605700 605710 707650 113956292580 292590 292640 605720 605730 605740 114827804070 EP-115393488700 488710 577700 577710 667420 667430 667460 EP-115394488750 577740 EP-115395577760 EP-115396488760 577770 EP-115398832600 PM555411430360 XL-115363169490 179400 488780 488790 488810 488830 488850 488870 488890 488900 488910 488920 515590 560180 560210 667480 667490 667500 667510 744780 744810 773080 XL-115364542280 542290 744850 744870 XL-115366502530 502540 502560 614450 666000 XL-115367630520 - 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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