PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 25, 2014 Initiated: April 15, 2014 #Z-1803-2014

Product Description

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.

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
102
Distribution
Nationwide Distribution.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet, Inc.. Units affected: 102.
Why was this product recalled?
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1803-2014.