Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations with 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. The hazard involves the use of medical devices in unapproved 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 where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The affected items include CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall involves 192,355 devices distributed nationwide in the United States and in Japan.
The recall is being conducted because surgeons are implanting these components in combinations that are not approved, specifically pairing micro components with standard components. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued. These devices are used in total knee arthroplasty for patients with severe pain.
Consumers and healthcare providers should contact Zimmer, Inc. for further information regarding the recall and proper device usage.
The recalled product
- Product
- 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total k
- Manufacturer
- Zimmer, Inc.
- 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.
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