DePuy Orthopaedics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0825-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 7, 2014

Date Posted: December 24, 2014

Recall Number: Z-0825-2015

Event ID: 69984

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

Status: Terminated

Product Quantity: 19 units worldwide

Code Information:

Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684

Distribution Pattern:

Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.

Voluntary or Mandated:

Voluntary: Firm initiated