Zimmer NexGen Knee Implant Recalled for Missing Inner Package Seal
Zimmer Manufacturing B.V. is recalling 179 NexGen System tibial components due to missing Tyvek seals on inner packaging, reported from Thailand.
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 involves a packaging defect (missing seal) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 179 units of the NexGen System, Complete Knee Solution Tibial Component, Precoat, Stemmed Size 3 (Reference Number 5980-37-01, Lot Number 62460264). The recall was initiated after complaints were received from Thailand indicating that the white paper (Tyvek) seal was missing from the inner package of the affected units.
The affected product is indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty. The distribution pattern for these units includes the US and Thailand.
Consumers and healthcare providers should check their inventory for this specific lot number and reference number. If the product is found, it should be removed from use and returned to the manufacturer or an authorized representative for further instructions.
The recalled product
- Product
- Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 179
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)
- lot #62460264
Distribution
Distribution scope not specified by the agency.
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