Z-1802-2014Class II

EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile...

Name: Z-1802-2014 EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile...
Creator: Biomet, Inc.
Published: 2014-04-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-04-15 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in... on 2014-04-15. FDA classified it as Class II and gives the reason as "The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1802-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-15
Posted: 2014-06-16
Terminated: 2015-07-07
Recalling firm: Zimmer GmbH
Product: EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.
Quantity in commerce: 100 units
Distribution: Nationwide Distribution.
Product codes and lots: Part numbers 110007379 Lot 060830 and 258920,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1802-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1801-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1802-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16
Z-1803-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16

Product code LXH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)