The Recall Desk
HighFDA (Devices)·Z-2043-2013·Announced 2013-08-28

Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations

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

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 is classified as FDA Class II, and the hazard involves the use of unapproved medical device combinations, which presents a risk of harm even though specific injuries are not detailed in the source text.

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 used in total knee arthroplasty.

The recall is being conducted because surgeons are implanting these components in combinations that are not approved, specifically mixing micro components with standard components. A previous recall in March 2012 reiterated proper combination labeling, but the mismatch problem has continued.

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

The recalled product

Product
00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx,
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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