Recalls / —

—#71984

Product

Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.

FDA product code

KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Device class

Class 3

Medical specialty

Orthopedic

510(k) numbers

K033634

Affected lot / code info

Lot 2299218.

Why it was recalled

The wrong part may be in the package. Package may contain a 28 mm head.

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer notified consignees via recall letter dated 6/20/08 to return the product.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Florida, Pennsylvania, Texas and Virginia.

Timeline

Recall initiated

2008-06-30

Posted by FDA

2008-09-17

Terminated

2009-01-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #71984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.