—#85809

Product

Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.

FDA product code: HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041549
Affected lot / code info: Lot 60947164.

Why it was recalled

Some of the devices may possess a taper which will not mate with the humeral head, as intended.

Root cause (FDA determination)

Other

Action the firm took

Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2009-09-17
Posted by FDA: 2009-11-12
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.