FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Green Mamba Suture Passer
- Recall number
- Z-0472-2016
- Recalling firm
- Biomet, Inc.
- Product
- Green Mamba Suture Passer
- Status
- Terminated
- Initiated
- 2015-12-02
- Posted
- not on file
- Terminated
- 2016-10-27
- 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.
- Root cause
- 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
- 13
- Distribution
- FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
- Lot, serial or model codes
- Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWQ
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28