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Terminated

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.

FDA Recall Z-1802-2014 · Posted 2014-06-16

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-04-15
Date Terminated2015-07-07
Product Quantity100 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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