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FDAJune 5, 2017device

COMP PRIMARY STEM 8MM MINI, model # 113628

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

The hazard

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

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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COMP PRIMARY STEM 8MM MINI, model # 113628 — Recall Details · AllClear