—#72786

Product

Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K062250, K081620
Affected lot / code info: All lots.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-07-10
Posted by FDA: 2009-01-15
Terminated: 2009-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.