Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer is recalling NexGen CR knee 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer, Inc. is recalling 192,355 units of the NexGen Cruciate Retaining (CR) Complete Knee System components, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall is due to surgeons implanting these components in combinations that are not approved, specifically mixing micro and standard components.
The affected devices are used in total knee arthroplasty and are indicated for patients with severe pain. The distribution pattern includes nationwide distribution in the USA and the country of Japan. A previous recall in March 2012 reiterated proper combination labeling, but the mismatch problem continues.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions on the recall.
The recalled product
- Product
- 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ 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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