Recall Z-0056-2015
Biomet, Inc. · initiated September 26, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Codes / lots: Catalog Number: 110010849 Lot Number: 169620, 253190
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0056-2015
- Initiated
- September 26, 2014
- Posted by FDA
- October 9, 2014
- Terminated
- July 14, 2015
- Product code
- HWQ – Passer
- Quantity
- 15 units
- Distribution
- Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0057-2015 Class II | Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to…An investigation identified that high level friction may exist between the needle and Mamba suture passer… | 09/26/2014Terminated |
| Z-0058-2015 Class II | Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are…An investigation identified that high level friction may exist between the needle and Mamba suture passer… | 09/26/2014Terminated |