Z-0825-2015Class II

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

Name: Z-0825-2015 Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-11-07
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-11-07 / Terminated

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2014-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0825-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Posted: 2014-12-17
Terminated: 2015-03-24
Recalling firm: Depuy Orthopaedics Inc.
Product: 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 code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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
FDA root cause: Mixed-up of materials/components
Action: 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).
Quantity in commerce: 19 units worldwide
Distribution: Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
Product codes and lots: Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0825-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

Product code LZO

K071830Class IIDepuy Delta Ts Ceramic Femoral HeadsDePuy Orthopaedics, Inc. / cleared 2007-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)