DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2018 - (Recall #: Z-0695-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 31, 2017

Date Posted: March 7, 2018

Recall Number: Z-0695-2018

Event ID: 79117

Reason for Recall:

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

Status: Terminated

Product Quantity: 15,678

Code Information:

Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated