Device product
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.
Z-1803-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 68216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 102
- Official record key
device-enforcement:Z-1803-2014
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 # 904050 Lots M224900, M175380, M060840,Part ##904051 Lots M224930, M224970, M175390 and M060850,Part # 904052 Lots M298610, M225000, M225010, and M060860; Part #904053 Lots M225030, M225020 and M048380; Part # 904054 Lots M225040, M225050, M175420, M060870; Part # 904055 Lot M060880; and Part # 904056 Lots M225100, M175440, and M060890.
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.