Z-0471-2016Class II

Black Mamba Suture Passer

Name: Z-0471-2016 Black Mamba Suture Passer
Creator: Biomet, Inc.
Published: 2015-12-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-12-02 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Black Mamba Suture Passer on 2015-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0471-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Posted: 2015-12-23
Terminated: 2016-10-27
Recalling firm: Zimmer GmbH
Product: Black Mamba Suture Passer
Product code: HWQ 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.
Root cause tag: manufacturing process
FDA 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 in commerce: 50
Distribution: FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
Product codes and lots: Catalog Number: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0471-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0471-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23
Z-0472-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code HWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)