Zimmer NexGen Knee Implant Drill Guide Recalled for Fit Issues
Zimmer Trabecular Metal Technology is recalling 8 units of NexGen Complete Knee Solution drill guides because two units did not fit the handle during cleaning.
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 issue is a functional fit problem during cleaning with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Trabecular Metal Technology, Inc. is recalling 8 units of the NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide (Tibial Size 5, Femoral Size Green / CH). The recall was initiated because two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle during cleaning.
The affected products are identified by Part number 00-5887-045-00 and Lot number 62592928. The products were distributed worldwide, including in the United States, Australia, and Denmark.
Consumers and healthcare providers should stop using the affected units and contact Zimmer Trabecular Metal Technology, Inc. for instructions on return or replacement.
The recalled product
- Product
- NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Hazard
- Affected units
- 8
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)
- Part number 00-5887-045-00 Lot number 62592928
Distribution
Distribution scope not specified by the agency.
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