Zimmer Biomet Recalls NexGen Offset Stem Extension Implants Due to Labeling Errors
Zimmer Biomet is recalling specific lots of NexGen Offset Stem Extension implants because the size etched on the parts and packaging was incorrect.
What this means for you
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 labeling error (incorrect size) which is a moderate risk of harm but does not involve reported injuries or high-risk pathogens.
Plain-English summary
Zimmer Biomet, Inc. is conducting a lot-specific field action for two lots of NexGen Offset Stem Extension implants, sizes 14mm and 17mm. These medical devices are used in total arthroplasty procedures. The recall involves 24 units distributed worldwide, including the United States and several international countries.
The field action was initiated because product complaints indicated that the size etched on the implant parts and the size labeled on the product packaging were incorrect. This discrepancy creates a risk of using the wrong size implant during surgery.
Healthcare providers and facilities that have received these specific lots should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of them. Patients who have already had these implants placed should contact their surgeon or healthcare provider to discuss the potential implications of the labeling error.
The recalled product
- Product
- NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 24
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 (9)
- Item Number: 00-5988-020-14
- Lot Number: 63463357
- Description: NexGen Offset Stem Ext Size 14
- UDI: (01)00889024221475(17)260930(10)63463357
- Item Number: 00-5988-020-17
- Lot Number: 63463367
- Description: (01)00889024221505(17)260930(10)63463367
- Manufactured Date: 9/19/2016
- Expiration Date: 9/30/2026
Distribution
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