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FDA-Device2013-08-28Class II

00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional

Zimmer, Inc.
Hazard

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Sold states
Worldwide Distribution-USA (nationwide) and the country of Japan.
Affected count
192,355 all devices
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional CR PROV FRM COMP SIZE DMR, Rx, Sterile; 00597101503 Provisional CR PROV FRM COMP SIZE EML, Rx, Sterile; 00597101504 Provisional CR PROV FRM COMP SIZE EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2013

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