Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the fe

FDA device recall Z-0825-2015 · posted 2014-12-17 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

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

Action taken

On 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). For questions about device recall information provided, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

LZO

Quantity affected

19 units worldwide

Distribution

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

Date initiated

2014-11-07

Date posted

2014-12-17

Date terminated

2015-03-24

Location

Warsaw, IN

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