Z-0695-2018 Class II Terminated
FDA device recall Z-0695-2018 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Aug 31, 2017 and is designated Class II. Reason for recall: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 15,678.
Recall details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Aug 31, 2017
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,678
Product description
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
Reason for recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Distribution pattern
US Nationwide Distribution
Code information
Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0695-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026