Black Mamba Suture Passer
Reported: December 30, 2015 Initiated: December 2, 2015 #Z-0471-2016
Product Description
Black Mamba Suture Passer
Reason for Recall
There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 50
- Distribution
- FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Black Mamba Suture Passer. Recalled by Biomet, Inc.. Units affected: 50.
Why was this product recalled? ▼
There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0471-2016.
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