Z-0825-2015 Class II Terminated
FDA device recall Z-0825-2015 was initiated by DePuy Orthopaedics, Inc. on Nov 7, 2014 and is designated Class II. 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… The recall status is terminated (terminated Mar 24, 2015). Affected quantity: 19 units worldwide.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 24, 2014
- Initiation Date
- Nov 7, 2014
- Termination Date
- Mar 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units worldwide
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.
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 Pattern
Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
Code Information
Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0825-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026