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FDAJune 29, 2022device

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

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

The hazard

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

What to do

FDA enforcement status: Ongoing

Brands named

depuy orthopaedicsdepuy

UPCs

10603295434061

Recall history

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

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ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525 — Recall Details · AllClear