PlainRecalls
FDA Devices Moderate Class II Terminated

00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with seve

Reported: August 28, 2013 Initiated: June 7, 2013 #Z-2042-2013

Product Description

00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
192,355 all devices
Distribution
Worldwide Distribution-USA (nationwide) and the country of Japan.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.. Recalled by Zimmer, Inc.. Units affected: 192,355 all devices.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Moderate. Recall number: Z-2042-2013.

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