FDA-Device2014-06-25Class II

EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

Biomet, Inc.
Hazard

The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Sold states
Nationwide Distribution.
Affected count
102
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2014

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