Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen Knee System components because surgeons are implanting them in unapproved combinations, creating a risk of improper fit.
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 medical devices in unapproved combinations, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves 192,355 devices, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. These devices are used in total knee arthroplasty for patients with severe pain and were distributed nationwide in the United States and in Japan.
The recall is being conducted because surgeons are implanting the components 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 has continued. Zimmer is removing the devices to prevent these unapproved combinations from being used in surgical procedures.
Healthcare providers who have received these devices should stop using them and contact Zimmer for instructions on how to return or dispose of the product. Patients who have already had these components implanted should contact their surgeon to discuss the specific combination used in their surgery and any potential implications.
The recalled product
- Product
- 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17,
- 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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