Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer 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 involves a high-risk medical device where improper use (unapproved combinations) presents 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 NexGen Cruciate Retaining (CR) Complete Knee System components, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall involves 192,355 devices distributed nationwide in the USA and in Japan.
The recall is being conducted because surgeons are implanting components in combinations that are not approved, specifically combining micro components with standard components. A previous recall in March 2012 reiterated proper combination labeling, but the mismatch problem continues. Zimmer is removing the devices from the market to address this issue.
The recalled product
- Product
- 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
- Manufacturer
- Zimmer, Inc.
- 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.
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