Device product
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.
Z-1802-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 68216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-1802-2014
Official wording
Reason: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
Code information: Part numbers 110007379 Lot 060830 and 258920,
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.