The Recall Desk
HighFDA (Devices)·Z-2037-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the hazard is the use of unapproved component combinations. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' as no specific injuries or illnesses are cited in the source text.

Plain-English summary

Zimmer, Inc. is recalling 192,355 units of the NexGen Cruciate Retaining (CR) Complete Knee System. The affected products include CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. These devices are used in total knee arthroplasty for patients with severe pain.

The recall is being conducted because surgeons are implanting the components in combinations that are not approved, specifically combining micro components with standard components. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem continues. Zimmer is removing the devices from the market to address this issue.

The affected devices were distributed nationwide in the United States and in Japan. Patients who have had these knee implants should contact their surgeon or healthcare provider for more information regarding the recall and potential next steps.

The recalled product

Product
00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Ster
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
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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