Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through so
FDA device recall Z-0057-2015 · posted 2014-10-09 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
- Action taken
- On 9/26/2014, "URGENT MEDICAL DEVICE RECALL NOTICE" notifications were sent via courier to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, contact information, and instructions for responding to the formal recall notification.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWQ
- Quantity affected
- 12 units
- Distribution
- Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
- Date initiated
- 2014-09-26
- Date posted
- 2014-10-09
- Date terminated
- 2015-07-14
- Location
- Warsaw, IN
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