FDA Device recall Z-0471-2016
Black Mamba Suture Passer
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Black 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-0471-2016 |
| 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
Black 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: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Biomet
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
FDA Device · Class II · 2026-08-12 · Biomet
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0471-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.