DePuy Mitek, Inc., a Johnson & Johnson Co.: FDA recalls

FDA enforcement reports name DePuy Mitek, Inc., a Johnson & Johnson Co. as the recalling firm in 16 events. The events have 51 product records. The recalls started from 2012 to 2025. All the events are device recalls.

See the 16 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

16 events, newest first.

FDA enforcement events of DePuy Mitek, Inc., a Johnson & Johnson Co.
Initiated	Product (first record)	Type	Class	Records	Status
24 Feb 2025	COR Disposable Kit, 8 mm. Cartilage Transplant System.	Device	Class II	2	Ongoing
13 Apr 2023	DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724	Device	Class II	5	Ongoing
4 Nov 2019	Healix Knotless ADV BR 4.75 Suture Anchor	Device	Class II	2	Terminated
30 Aug 2018	Mitek Screw and Washer Depth Gauge, Product Code 219024	Device	Class II	1	Terminated
22 Dec 2017	LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.	Device	Class II	1	Terminated
31 Aug 2017	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.	Device	Class II	1	Terminated
12 May 2017	DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft	Device	Class II	5	Terminated
23 Nov 2015	VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)	Device	Class II	1	Terminated
20 Nov 2015	FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.	Device	Class II	3	Terminated
29 Aug 2013	DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components…	Device	Class II	2	Terminated
15 Apr 2013	DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.	Device	Class II	1	Terminated
22 Mar 2013	ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.	Device	Class II	5	Terminated
16 Nov 2012	DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.	Device	Class II	1	Terminated
6 Sep 2012	SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow	Device	Class II	16	Terminated
4 May 2012	Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.	Device	Class II	4	Terminated
12 Mar 2012	DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

DePuy Mitek, Inc., a Johnson & Johnson Co.: events for each product type
Type		Events
Device		16

DePuy Mitek, Inc., a Johnson & Johnson Co.: events in each class
Class		Events
Class II		16

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of DePuy Mitek, Inc., a Johnson & Johnson Co., by the year that the recall started. The largest year is 2012, with 4 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. DePuy Mitek, Inc., a Johnson & Johnson Co.: FDA recalls. https://recallregister.com/firm/depuy-mitek-inc-a-johnson-johnson-co/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of DePuy Mitek, Inc., a Johnson & Johnson Co. have?: Class II: 16 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of DePuy Mitek, Inc., a Johnson & Johnson Co.?: FDA event 96347, which the firm started on 24 Feb 2025. The first product in the record is: COR Disposable Kit, 8 mm. Cartilage Transplant System.
How many FDA recalls of DePuy Mitek, Inc., a Johnson & Johnson Co. have the status Ongoing?: 2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.