Zimmer Biomet Recalls M/L Taper Hip Prosthesis Due to Etching Error
Zimmer Biomet is recalling a specific lot of M/L Taper Hip Prostheses because the device was incorrectly etched as 'STD' instead of 'EXT', although the packaging is 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 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, but the hazard is a labeling/etching discrepancy where the physical device matches the correct packaging, representing a minor labeling error without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. initiated a voluntary recall on February 11, 2016, for a single manufacturing lot of M/L Taper Hip Prostheses. The affected product is Item 00-7711-012-20, Lot 62937093, specifically Size 12.5, Extended Offset stems. A total of 9 units are involved in this recall.
The recall was initiated because the device was incorrectly etched with the label 'STD' rather than 'EXT'. Despite this error on the device itself, the product packaging is correctly labeled as 'Extended Offset,' and the device is indeed an extended offset stem.
The affected units were distributed in the states of South Dakota, Missouri, New York, Michigan, Pennsylvania, Kentucky, and Tennessee, as well as in the country of Argentina. Consumers and healthcare providers should verify the item and lot numbers of any M/L Taper Hip Prostheses in their possession against the recalled codes and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 9
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: 00-7711-012-20
- Lot: 62937093
Distribution
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