Zimmer Biomet Recalls Mislabeled Trabecular Metal Primary Hip Prostheses
Zimmer Biomet is recalling 24 units of Trabecular Metal Primary Hip Prostheses due to mislabeling. The affected devices were distributed in the US and several international countries.
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 involves mislabeling, which aligns with the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling 24 units of Trabecular Metal Primary Hip Prostheses. The recall involves two specific part numbers: 00-7864-013-00 (Lot 63703649) and 00-7864-013-20 (Lot 63703681). The reason for the recall is that these hip implants are mislabeled.
The affected devices were distributed in two US states (Louisiana and New York) as well as in Canada, China, Japan, and Switzerland. The source text does not specify the exact nature of the mislabeling or report any associated injuries or illnesses.
Healthcare providers and patients should verify the part numbers and lot numbers of their devices against the recall information. If a device matches the recalled lots, providers should contact Zimmer Biomet for instructions on how to proceed.
The recalled product
- Product
- Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
- 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 (4)
- Part Numbers: 1. 00-7864-013-00
- Lot: 63703649
- 2. 00-7864-013-20
- Lot: 63703681
Distribution
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