FDA Device recall Z-0472-2016
Green Mamba Suture Passer
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Green Mamba Suture Passer by Biomet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0472-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-02 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | AL, AR, CA, FL, GA, HI, IN, KS, KY, LA, MN, MO, NC, NJ, NY, OH, TX, UT, VA, WI |
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.
Identifiers
| code_info | Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0472-2016%22
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