Z-0058-2015Class II

Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing...

Name: Z-0058-2015 Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing...
Creator: Biomet, Inc.
Published: 2014-09-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-09-26 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is... on 2014-09-26. FDA classified it as Class II and gives the reason as "An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use". 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-0058-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Posted: 2014-10-09
Terminated: 2015-07-14
Recalling firm: Zimmer GmbH
Product: Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Product code: HXQ Crimper, Pin
Reason for recall: An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 9/26/2014, "URGENT MEDICAL DEVICE RECALL NOTICE" notifications were sent via courier to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, contact information, and instructions for responding to the formal recall notification.
Quantity in commerce: 164 units
Distribution: Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Product codes and lots: Catalog Number: 110010851 Lot Number: 139800, 139810, 139820

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0058-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0056-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0057-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0058-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09

Product code HXQ

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)