Zimmer NexGen Knee Implant Recall Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling NexGen knee implant components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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 manufacturing process issue (sealer calibration) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific NexGen knee implant components, including tibial plates, stemmed tibial components, sharp fluted stems, and straight stem extensions. The recall affects products packaged in the firm's Building II between August 2010 and April 2013.
The recall is being conducted because of insufficient sealer calibration data for the affected sterile products. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers and healthcare providers should contact Zimmer Manufacturing B.V. for instructions on how to handle the affected devices.
The recalled product
- Product
- Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 202,221
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. 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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Similar recalls
- ModerateZimmer Recalls NEXGEN Knee Implant Components Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- HighZimmer Recalls NexGen Knee Components Due to Stem Locking Failure
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- ModerateZimmer NexGen Knee Implant Recalled for Missing Inner Package Seal
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- ModerateZimmer NexGEN Tibial Components Recalled Due to Labeling Error
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- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
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