Zimmer NexGen LPS Femoral Component Recalled for Packaging Defect
Zimmer is recalling 7 NexGen LPS Femoral Components because undersized foam inserts may allow the inner cavity to breach during shipping.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging defect that may compromise the device during transport, which fits the criteria for a moderate severity recall without reported injuries.
Plain-English summary
Zimmer Orthopedic Mfg Ltd is recalling 7 units of the NexGen LPS Femoral Component, Left and Right, Size G. These medical devices are used to replace the femoral condyle of the knee joint during Total Knee Arthroplasty. The recall is due to a potential defect in the packaging where the protective foam insert may be undersized.
The undersized foam insert may cause a breach in the inner cavity of the device during transportation. The affected devices were distributed worldwide, including to the US states of California, Massachusetts, Maine, Michigan, Minnesota, and Wisconsin, as well as to Germany, France, and Italy. The specific item number is 00-5964-017-51, and the affected lot numbers are 63329529, 63342472, 63329533, and 63329527.
Healthcare providers and facilities should check their inventory for these specific lot numbers. If the devices are found, they should be removed from use and returned to the manufacturer or the distributor in accordance with the recall instructions. Patients who have already had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
- Manufacturer
- ZIMMER ORTHOPEDIC MFG LTD
- Affected units
- 7
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 (4)
- Item Number: 00-5964-017-51
- 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472)
- 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533)
- 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
Distribution
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