NexGen CR-Flex Femoral Components Recalled for Bonding Defect
Zimmer is recalling 5,546 units of NexGen CR-Flex Femoral Components due to a manufacturing defect where the fiber metal pad fails to bond properly to the substrate. Patients with these implants should contact their healthcare provider.
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: This is a Class II recall affecting orthopedic implants with a real manufacturing defect that could compromise implant function. However, no illnesses or injuries have been reported. Per FDA guidelines, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Zimmer, Inc. is recalling 5,546 units of NexGen CR-Flex Femoral Components (Size E and Size E Minus models), which are components of the NexGen CR-Flex Porous Femur System. The recalled devices were distributed worldwide, including throughout the United States, Australia, Canada, Japan, and the Netherlands.
The recall stems from an out-of-specification manufacturing defect. A gap in the fixture that presses the fiber metal pad to the substrate causes the pad to fail to bond fully to the substrate. This affects the performance of the implant component.
Patients who have received these components should contact their healthcare provider to determine if their implant is affected. Healthcare providers should immediately stop using affected inventory and refer to FDA and Zimmer communications regarding the specific lot codes associated with the recall.
The recalled product
- Product
- NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 5,546
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 (20)
- Item No. 00595201501
- 00595201502
- 00595201505
- 00595201506
- UDI:(01)00889024207806(17)280731(10)64115713
- (01)00889024207806(17)280930(10)64175075
- (01)00889024207806(17)280930(10)64175076
- (01)00889024207790(17)280930(10)64175073
- (01)00889024207806(17)280930(10)64138317
- (01)00889024207790(17)281031(10)64175074
- (01)00889024207790(17)281031(10)64194991
- (01)00889024207790(17)281031(10)64202116
- (01)00889024207806(17)281031(10)64178998
- (01)00889024207813(17)281031(10)64179054
- (01)00889024207790(17)281031(10)64202117
- (01)00889024207813(17)281031(10)64179043
- (01)00889024207813(17)281031(10)64194989
- (01)00889024207790(17)281031(10)64178996
- (01)00889024207790(17)281031(10)64178997
- (01)00889024207790(17)281031(10)64179023
Distribution
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