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FDASeptember 20, 2022device

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.

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

The hazard

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

What to do

FDA enforcement status: Ongoing

Brands named

baxter healthcarebaxter

UPCs

00615521012731

Recall history

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

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Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures. — Recall Details · AllClear