Biomet Recalls Green Mamba Suture Passers Due to Needle Breakage Risk
Biomet, Inc. is recalling 12 units of Green Mamba Suture Passers because high friction may cause the needle to break during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (needle breakage) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Biomet, Inc. is recalling 12 units of the Green Mamba Suture Passer. The affected products are sterile, disposable, single-patient use instruments designed to aid in passing suture through soft tissue. The recall involves specific catalog and lot numbers identified in the agency's records.
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 products were distributed nationwide, including in Florida, New York, Texas, Virginia, Nevada, Michigan, California, Indiana, South Dakota, Georgia, Kentucky, North Carolina, and Arkansas.
Healthcare providers and patients who have used or possess these specific units should stop using them immediately. Users should contact Biomet, Inc. for instructions on how to return the devices or obtain a replacement, as directed by the recalling firm.
The recalled product
- Product
- Green Mamba Suture Passer. 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
- 12
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 (2)
- Catalog Number: 110010850 Lot Number: 231120
- 253210
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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