FDAAugust 21, 2019device

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

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

The hazard

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biometzimmer

UPCs

008878682264410088030480418000880304860001008803044430440088030443412700880304433496

Recall history

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

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BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement — Recall Details · AllClear