Z-1803-2014 Class II Terminated
FDA device recall Z-1803-2014 was initiated by Biomet, Inc. on Apr 15, 2014 and is designated Class II. 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. The recall status is terminated (terminated Jul 7, 2015). Affected quantity: 102.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 25, 2014
- Initiation Date
- Apr 15, 2014
- Termination Date
- Jul 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102
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.
Distribution Pattern
Nationwide Distribution.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1803-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026