DePuy Orthopaedics, Inc.: Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage

Is my product affected?

Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.

• UPC 10603295033684

Check against the official notice below — it lists the full affected range.

What happened

DePuy Orthopaedics, Inc. is recalling 19 units of the BIOLOX delta TS Ceramic Femoral Head (product code 1365-36-740, lot 7928614) used in hip replacement surgery. Two complaints reported that the device did not fit as expected during surgery, with the hip construct feeling loose due to improper tissue tension rather than a problem with the connection between the femoral head and stem. The investigation determined that a small size sleeve with incorrect femoral head offset was used during manufacturing.

The affected devices were distributed to West Virginia, Arizona, and Alabama in the United States, as well as to Germany and Finland. The source document does not specify what remedy an affected consumer should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the

Details from the source

Reason for recall: Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the Distribution: Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland. Quantity: 19 units worldwide Lot/code info: Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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