Z-1801-2014 Class II Terminated
FDA device recall Z-1801-2014 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: 100 units.
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
- 100 units
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Part numbers 110007380 Lot 223570 and 803860
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1801-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026