Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 source text does not report any illnesses, injuries, or hospitalizations, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 192,355 units of the NexGen Cruciate Retaining (CR) Complete Knee System, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall covers devices distributed nationwide in the United States and in Japan.
The recall is being conducted because surgeons are implanting components of the system 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 to address this issue.
The recalled product
- Product
- 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
- 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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