—#80210

Product

Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023528
Affected lot / code info: All lots.

Why it was recalled

The tibial spacer will not affix to the distal surface of the baseplate, as intended.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Zimmer, Inc. issued an "Urgent-Device Recall" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. Further questions should be addressed to 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 - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.

Timeline

Recall initiated: 2009-03-18
Posted by FDA: 2009-06-30
Terminated: 2009-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.