—#28000

Product

Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K911684
Affected lot / code info: lots 382010, 402898, 447968, 453654, 490929

Why it was recalled

The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.

Root cause (FDA determination)

Other

Action the firm took

Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.

Recalling firm

Firm: Biomet, Inc.
Address: 56 East Bell Drive, Warsaw, Indiana 46582

Distribution

Distribution pattern: United States

Timeline

Recall initiated: 2003-06-18
Posted by FDA: 2003-09-24
Terminated: 2003-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.