Z-0533-2009

Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device...

Name: Z-0533-2009 Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device...
Creator: Depuy Orthopaedics, Inc.
Published: 2008-07-10
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2008-07-10 / Terminated / root cause: design

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant on 2008-07-10. The reason FDA records is "Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0533-2009
Status: Terminated
Initiated: 2008-07-10
Posted: 2009-01-15
Terminated: 2009-10-28
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
Root cause tag: design
FDA root cause: Device Design
Action: A letter, "Urgent Device Correction" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.
Quantity in commerce: 1,521 of all devices.
Distribution: Nationwide Distribution.
Product codes and lots: All lots.

Product code KWS

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)