FDAJune 12, 2015device

ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a co...

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

The hazard

Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

106032951328371060329513284410603295132851106032951328681060329513287510603295132882

Recall history

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

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