Biomet Recalls CurvTek Eye Needles Due to Incorrect Inner Labeling
Biomet, Inc. is recalling 21 CurvTek Eye Needles because the inner label incorrectly identifies the product size and reference number.
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 a labeling error that could lead to the use of the wrong surgical instrument size, fitting the criteria for moderate severity due to potential for temporary or reversible harm.
Plain-English summary
Biomet, Inc. is recalling 21 units of CurvTek Eye Needles, Reference 906768, Lot 055450. The product is a 22 mm X-large stainless steel needle, single use and gamma sterilized. The recall is due to a labeling error where the inner label incorrectly states the product as Reference 906760, 7 mm Medium.
The affected units were distributed nationwide, including in Michigan, Iowa, Illinois, Indiana, and Tennessee. The outer box correctly identifies the product as the 22 mm X-large needle, but the inner label contains the incorrect reference number and size description.
Healthcare providers and consumers should stop using these specific needles and contact Biomet, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible health consequences.
The recalled product
- Product
- outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 21
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)
- Lot 055450
Distribution
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