Recall Z-0472-2016
Biomet, Inc. · initiated December 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Green Mamba Suture Passer
Codes / lots: Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 12/2/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors and hospital risk managers via courier with instructions to locate and return the affected products. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-0472-2016
- Initiated
- December 2, 2015
- Terminated
- October 27, 2016
- Product code
- HWQ – Passer
- Quantity
- 13
- Distribution
- FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0471-2016 Class II | Black Mamba Suture PasserThere may be a separation and an insufficient weld between the spring and washer. The weld between the… | 12/02/2015Terminated |