Black Mamba Suture Passer — Class II medical device recall Z-0471-2016
Terminated recall by Biomet, Inc., reported 2015-12-30, distributed in AL, AR, CA, FL, GA, HI, IN, KS…. There may be a separation and an insufficient weld between the spring and washer. The weld between the spring
| Recall number | Z-0471-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-12-02 |
| Classified | 2015-12-23 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-10-27 |
| Distributed | AL, AR, CA, FL, GA, HI, IN, KS, KY, LA, MN, MO, NC, NJ, NY, OH, TX, UT, VA, WI |
| Quantity | 50 |
| Reason classes | device malfunction |
| Model numbers | 110010849 |
Product
Black Mamba Suture Passer
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0471-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.