PlainRecalls
FDA Devices Moderate Class II Terminated

EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

Reported: June 25, 2014 Initiated: April 15, 2014 #Z-1801-2014

Product Description

EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

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
100 units
Distribution
Nationwide Distribution.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.. Recalled by Biomet, Inc.. Units affected: 100 units.
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-1801-2014.