| Class 2 Device Recall Biomet Green Mamba Suture Passer | |
Date Initiated by Firm | December 02, 2015 |
Create Date | December 23, 2015 |
Recall Status1 |
Terminated 3 on October 27, 2016 |
Recall Number | Z-0472-2016 |
Recall Event ID |
72829 |
Product Classification |
Passer - Product Code HWQ
|
Product | Green Mamba Suture Passer |
Code Information |
Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | Audrey Daenzer 574-372-1570 |
Manufacturer 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 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | 13 |
Distribution | FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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