Zimmer Biomet Recalls 36mm Modular Hip Head Due to Incorrect Etching
Zimmer Biomet is recalling 23 units of 36mm Modular Hip Heads because one piece was incorrectly etched with the wrong offset size.
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 source text describes a labeling/etching error affecting functional use without reporting any injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for minor labeling errors or low-risk issues where no harm has been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 23 units of the 36MM COCR MODULAR HD -6MM product. The recall is due to a labeling and functional error where one piece from a different lot was mixed with lot 236840. This specific piece is incorrectly etched as -6MM offset instead of the correct +3MM offset.
The incorrect etching and the resulting size difference affect the functional use of the product. Because of this functional impact, the affected lot is being removed from the field. The distribution pattern for this recall is listed as outside the USA.
Healthcare providers and distributors should stop using the affected product immediately. Consumers or patients who have received this specific product should contact their healthcare provider or Zimmer Biomet for further instructions on how to proceed.
The recalled product
- Product
- 36MM COCR MODULAR HD -6MM
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 23
Distribution
Distribution scope not specified by the agency.
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