Z-0471-2016 Class II Terminated
FDA device recall Z-0471-2016 was initiated by Biomet, Inc. on Dec 2, 2015 and is designated Class II. 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… The recall status is terminated (terminated Oct 27, 2016). Affected quantity: 50.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 30, 2015
- Initiation Date
- Dec 2, 2015
- Termination Date
- Oct 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50
Product Description
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.
Distribution Pattern
FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
Code Information
Catalog Number: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0471-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026