FDAFebruary 17, 2017device

various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biometzimmer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement — Recall Details · AllClear