Biomet Recalls Green Mamba Suture Passers Due to Weld Fracture Risk
Biomet is recalling 13 Green Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.
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 3/5 (High).
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 is classified as FDA Class II. The hazard involves a mechanical failure of a surgical instrument that could lead to improper actuation during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 13 units of the Green Mamba Suture Passer (Catalog Number 110010850). The recall involves specific lot numbers: 167890, 231120, 253210, 550050, 551580, 716300, and 953230. The affected products were distributed to facilities in 20 states, including Florida, New Jersey, Wisconsin, Utah, Texas, Kentucky, Kansas, Ohio, Georgia, Louisiana, Alabama, New York, North Carolina, Arkansas, Missouri, Virginia, California, Minnesota, Indiana, and Hawaii.
The recall is being conducted because there may be a separation and an insufficient weld between the spring and washer components. This defect may cause the weld to fracture, which could result in the Mamba Suture Passer instrument's jaw not actuating properly. The FDA has received 6 complaints regarding this issue, with 3 of those complaints reporting a delay of up to 10 minutes in actuation.
Healthcare providers and facilities that have received these specific units should stop using them and contact Biomet, Inc. for instructions on return or replacement. Patients who have had surgery using these instruments should contact their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- Green Mamba Suture Passer
- Manufacturer
- Biomet, Inc.
- Affected units
- 13
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 (7)
- Catalog Number: 110010850 Lot Number Identification: 167890
- 231120
- 253210
- 550050
- 551580
- 716300
- 953230
Distribution
Part of a larger recall action
This product is one of 2 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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