Recall Z-0472-2016— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2015-12-02, terminated 2016-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Green Mamba Suture Passer. Reason: 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-02
- Terminated
- 2016-10-27
- Firm location
- Warsaw, IN, United States
Product description
Green 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.