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Terminated

Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant.

FDA Recall Z-0533-2009 · Posted 2009-01-15

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2008-07-10
Date Terminated2009-10-28
Product Quantity1,521 of all devices.

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081620MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEMDePuy Orthopaedics, Inc. · 2008-06-30K062250DELTA XTEND REVERSE SHOULDER SYSTEMDePuy Orthopaedics, Inc. · 2007-02-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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