Biomet Recalls EZPass Nylon Monofilament Suture Passers Due to Buckling
Biomet is recalling 100 units of EZPass Nylon Monofilament Suture Passers because the internal wire may buckle, making the instrument difficult to use.
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. The hazard is a functional defect (buckling/kinking) that makes the instrument difficult to use, but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
Biomet, Inc. is recalling 100 units of EZPass Nylon Monofilament Single Packs (Part number 110007379). These are sterile, single-use orthopedic manual surgical instruments used in arthroscopic procedures to aid in passing suture through soft tissue. The affected lots are 060830 and 258920, and the products were distributed nationwide.
The recall is being issued because the nitinol wire or monofilament inside the EZPass Suture Passer may buckle and become kinked. This defect makes the wire or monofilament difficult to use during surgical procedures.
Healthcare facilities and users should stop using the affected units and contact Biomet, Inc. for instructions on how to return the products.
The recalled product
- Product
- EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 100
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 numbers 110007379 Lot 060830 and 258920
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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