Zimmer Biomet Recalls NexGen Knee Augment Blocks Due to Missing Screws
Zimmer Biomet is recalling 19 NexGen Complete Knee Solution Femoral Augment Blocks because a screw is missing from the package.
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 missing component (screw) which is a packaging/assembly issue rather than a direct biological or structural failure causing injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19 units of the NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw (Item Number: 00599003523). The recall is due to a screw being missing from the package. The affected lot number is 62925336.
The product is a medical device used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle. The units were distributed worldwide, including in the United States (Ohio, Florida, New Jersey, New York, Pennsylvania, Texas, and West Virginia) and in Canada, Australia, Japan, Germany, and the Netherlands.
Consumers and healthcare providers should check their inventory for this specific item number and lot number. If the product is found, it should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 19
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 Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336
Distribution
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