FDAFebruary 2, 2018device

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logic...

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

The hazard

This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.

What to do

FDA enforcement status: Terminated

Brands named

signature orthopedics ptysignaturesignature orthopedics

UPCs

09348215001926

Recall history

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

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