Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk
Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (needle breakage) in a medical device used during surgical procedures, which poses a significant risk of injury.
Plain-English summary
Biomet, Inc. is recalling 164 units of the Mamba Disposable Nitinol Needle. These sterile, disposable needles are designed for single-patient use with the Mamba Suture Passer to aid in passing suture through soft tissue. The affected products are identified by Catalog Number 110010851 and Lot Numbers 139800, 139810, and 139820.
The recall was initiated after an investigation identified that high-level friction may exist between the needle and the Mamba suture passer instrument. This friction can cause the needle to break during use. The agency has classified this as a Class II recall.
The affected needles were distributed nationwide, including in Florida, New York, Texas, Virginia, Nevada, Michigan, California, Indiana, South Dakota, Georgia, Kentucky, North Carolina, and Arkansas. Healthcare facilities and users should stop using the affected needles and contact Biomet, Inc. for instructions on returning the products.
The recalled product
- Product
- Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
- Manufacturer
- Biomet, Inc.
- Affected units
- 164
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)
- Catalog Number: 110010851 Lot Number: 139800
- 139810
- 139820
Distribution
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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