Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
FDA Recall Z-0227-2010 · Posted 2009-11-13
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-10-08
Date Terminated2011-05-16
Product Quantity26,404 of all products
Reason for Recall
The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Firm Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain 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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