—#82163

Product

Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics.

FDA product code: LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K992667
Affected lot / code info: Lot Number: 60698102.

Why it was recalled

The threads on the screw are incomplete/non-functional.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified "Urgent: Device Recall" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.

Timeline

Recall initiated: 2009-05-15
Posted by FDA: 2009-07-06
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.