FDAFDA · Food and drugs·Recall number Z-1802-2014
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.
Published June 25, 2014 · Recall initiated: April 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- Part numbers 110007379 Lot 060830 and 258920,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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