Biomet Black Mamba Suture Passer Recalled for Weld Defect
Biomet is recalling 50 Black Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.
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 mechanical defect that could lead to procedural failure (jaw not actuating), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Biomet, Inc. is recalling 50 units of the Black Mamba Suture Passer. The recall is due to a potential separation and insufficient weld between the spring and washer components. This defect may cause the weld to fracture, resulting in the instrument's jaw not actuating properly.
The affected units are identified by Catalog Number 110010849 and specific lot numbers: 167880, 169620, 253190, 520810, 538490, 551550, 716270, and 960180. The products were distributed in the following states: FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, and HI.
Six complaints have been received regarding this issue, three of which reported a delay of up to 10 minutes. Healthcare providers should stop using the affected devices and contact Biomet for instructions on return or replacement.
The recalled product
- Product
- Black Mamba Suture Passer
- Manufacturer
- Biomet, Inc.
- Affected units
- 50
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 (8)
- Catalog Number: 110010849 Lot Number Identification: 167880
- 169620
- 253190
- 520810
- 538490
- 551550
- 716270
- 960180
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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