FDAJune 12, 2015device

ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 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...

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

10603295135487106032951354941060329513550010603295135517106032951355241060329513553110603295135548106032951355551060329513556210603295135579

Recall history

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

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