Zimmer Biomet Recalls Mislabeled Bone Dowell Harvest Tubes
Zimmer Biomet is recalling 49 Bone Dowell Harvest Tubes that were mislabeled as 8mm but are actually 9mm in 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding size, which is a moderate risk.
Plain-English summary
Zimmer Biomet, Inc. is recalling 49 units of Bone Dowell Harvest Tubes. The recall was initiated because the product was mislabeled as an 8mm tube, but the actual size is 9mm.
The issue arose because a 9mm subcomponent was erroneously substituted for the actual 8mm subcomponent part and was etched with the incorrect 8mm marking. This labeling error could lead to the use of an incorrect size component during medical procedures.
The recalled products were distributed in Japan, the Netherlands, Singapore, and Switzerland. There is no US distribution of these specific units. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Bone Dowell Harvest Tubes
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 49
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 (1)
- Part Number: 900738 Lot Number (LN): 889990
Distribution
Distribution scope not specified by the agency.
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