FDAJanuary 24, 2024device

RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S

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

The hazard

Products not sterilized, sterility cannot be confirmed

What to do

FDA enforcement status: Ongoing

Brands named

synthes usa productssynthessynthes usa

UPCs

10887587057262

Recall history

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

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