The Recall Desk
HighFDA (Devices)·Z-2032-2013·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 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 poses a risk of harm even though specific injuries are not detailed in the provided text.

Plain-English summary

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

The recall is being conducted because a March 2012 recall had previously reiterated the proper combination labeling, but the mismatch problem continues. The devices are indicated for use in total knee arthroplasty for patients with severe pain. The recall covers 192,355 devices distributed nationwide in the USA and in Japan.

Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions on the recall and proper device handling.

The recalled product

Product
00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE G
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.

See all →

Same hazard · unapproved combination

See all →