Zimmer Recalls NexGen CR-Flex Tibial Components Due to Packaging Adhesion
Zimmer, Inc. is recalling NexGen CR-Flex Mobile Bearing Tibial Components because the packaging bags adhere to the device surfaces.
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, which corresponds to a High severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 3,475 units of the NexGen CR-Flex Mobile Bearing Tibial Component 9. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated because the low density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surfaces of the devices. This adhesion issue affects the packaging integrity of the medical components.
The affected products were distributed worldwide, including in the United States and numerous international markets. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these specific components.
The recalled product
- Product
- NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 3,475
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)
- Part Number Range:005930-010/080-01/02
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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