Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200. 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 Recall Z-1485-2009 · Posted 2009-06-30
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-03-18
Date Terminated2009-10-23
Product Quantity834 of all products
Reason for Recall
The tibial spacer will not affix to the distal surface of the baseplate, as intended.
Firm Action
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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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