Class II — DePuy Mitek, Inc., a Johnson & Johnson Co.
| Recalling firm | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|---|---|
| Registered facility | DePuy Mitek, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Leakage of FMS gravity tub sets (281113) at the bulb and tube connection |
| Product | 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. |
| Quantity | 15,678 |
| Distribution | US Nationwide Distribution |
| Initiated | 2017-08-31 |
| Classified | 2018-02-23 |
| Terminated | 2019-04-09 |
| Recall number | Z-0695-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Mitek, Inc., a Johnson & Johnson Co. (Z-0695-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79117/
Alerts for DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.