Zimmer Biomet Recalls Jamshidi Bone Marrow Aspiration Needles Due to Labeling Error
Zimmer Biomet is recalling 133 Jamshidi Bone Marrow Aspiration Needles because the outer expiration date may exceed the inner label date.
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 discrepancy regarding expiration dates without reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling 133 units of Jamshidi Bone Marrow Aspiration Needles (Item Number: 00-1103-007-00) distributed nationwide in the United States. The recall involves specific lot numbers: 62754464, 62904231, and 63060634.
The recall was initiated because the expiration date on the outer label applied by Zimmer Biomet may exceed the expiration date on the inner label. This discrepancy could lead to the use of the device beyond its intended shelf life.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected needles. Consumers are advised to contact their healthcare provider if they have received this product.
The recalled product
- Product
- Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 133
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 (3)
- Lot Numbers : 62754464
- 62904231
- 63060634
Distribution
Distributed nationwide across the United States.
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