The Recall Desk
HighFDA (Devices)·Z-2034-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining 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, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The issue is that surgeons are implanting these components in combinations that are not approved, specifically combining micro components with standard components.

The recall affects 192,355 devices distributed nationwide in the United States and in Japan. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued. Zimmer is removing the devices from the market to address this labeling and usage issue.

Healthcare providers should stop using the affected components and contact Zimmer for further instructions. Patients who have had these components implanted should consult their surgeon regarding the specific combination used in their procedure.

The recalled product

Product
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; 00597101
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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