Zimmer Recalls Trilogy Longevity Constrained Liners Due to Packaging Error
Zimmer, Inc. is recalling Trilogy Longevity Constrained Liners because they were packaged in incorrect cartons, although the product labels are correct.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only problem where the product labels are correct and match the contents, posing no direct health risk.
Plain-English summary
Zimmer, Inc. is recalling one unit of the Trilogy Longevity Constrained Liner, a medical device used as the articular surface for a femoral head in total hip arthroplasty. The recall is due to a packaging error where the devices were placed in incorrect cartons.
The source text confirms that while the cartons are incorrect, the product labels and patient labels are correct and match the product inside the carton. The affected item is identified as Item 00-6334-062-36, Lot 62023769.
The recall is distributed nationwide in the USA, including the states of Ohio, Carolinas, and New England. Healthcare providers and patients should verify that the product labels match the device before use, as the external carton may not correspond to the contents.
The recalled product
- Product
- Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
- Manufacturer
- Zimmer, 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 (2)
- Item 00-6334-062-36
- Lot 62023769
Distribution
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