The Recall Desk
SevereFDA (Devices)·Z-2042-2013·Announced 2013-08-28

Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving structural or usage defects in medical devices where injury reports may be present or the risk is significant.

Plain-English summary

Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves 192,355 devices, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals, which are being combined with standard components in ways that are not approved.

The recall is being conducted because surgeons are implanting these components in unapproved combinations, specifically mixing micro and standard parts. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued. The devices are indicated for patients with severe pain undergoing total knee arthroplasty.

The affected devices were distributed nationwide in the United States and in Japan. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the removal of these devices from use.

The recalled product

Product
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, Ster
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
192,355

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 47 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · unapproved combination

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