Zimmer NexGen Trabecular Metal Femoral Augment Block Mislabeled Recall
Zimmer Trabecular Metal Technology is recalling one unit of a NexGen femoral augment block that was mislabeled as 5 mm instead of 20 mm.
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 source text describes a labeling error without reporting any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Trabecular Metal Technology, Inc. is recalling one unit of the NexGen Trabecular Metal Femoral Augment Block Distal Only, 20 MM Augment, Size D. The product is intended for use in total knee arthroplasty where severe degeneration, trauma, or other pathology of the knee joint is present.
The recall was initiated because the 20 mm augment was mislabeled as a 5 mm augment before being distributed. The affected unit is identified by Part No. 00-5490-034-24 and Lot #613574282T. The distribution was limited to the state of California.
Healthcare providers and patients should verify the size of the implant used. If the mislabeled unit was implanted, providers should contact Zimmer Trabecular Metal Technology for further instructions.
The recalled product
- Product
- NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete…
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Hazard
- Affected units
- 1
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 (3)
- 20 MM - Part No. 00-5490-034-24
- Lot #613574282T 5 MM - Part No. 00549003410
- Lot #61357484T
Distribution
Distributed in 1 state:
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