Depuy Mitek, A Johnson & Johnson Company
Country not established
- Devices
- 66
- FDA recalls
- 927 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Depuy Mitek, A Johnson & Johnson Company makes
The company manufactures orthopaedic fixation devices for soft tissue and meniscal repair, including meniscal repair systems, suture anchors (e.g., QuickAnchor Plus, Micro QA+), interference screws (e.g., Milagro), and knotless anchors (e.g., Healix Advance, Gryphon BR). It also produces surgical blades like the Omnicut for tissue resection and loop anchors such as the Panalok.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Search and filter all 66 devicesShowing 1-50 of 66
FDA recalls
FDA recall records list 92 recalls initiated by Depuy Mitek, A Johnson & Johnson Company, the earliest on 2005-08-09 and the most recent on 2025-02-24. By recorded status: 7 ongoing and 85 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 7
- 2018 1
- 2019 2
- 2020 0
- 2021 0
- 2022 0
- 2023 5
- 2024 0
- 2025 2
- 2026 0
2025
- 24 Feb 2025 Z-1314-2025 Class II Ongoing Device is missing the pin in the graft loader component.
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- 24 Feb 2025 Z-1315-2025 Class II Ongoing Device is missing the pin in the graft loader component.
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- 24 Feb 2025 Z-1314-2025 Class II Ongoing Device is missing the pin in the graft loader component.
2023
- 13 Apr 2023 Z-1677-2023 Class II Ongoing IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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- 13 Apr 2023 Z-1678-2023 Class II Ongoing IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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- 13 Apr 2023 Z-1679-2023 Class II Ongoing IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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- 13 Apr 2023 Z-1680-2023 Class II Ongoing IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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- 13 Apr 2023 Z-1681-2023 Class II Ongoing IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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- 13 Apr 2023 Z-1677-2023 Class II Ongoing IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
2019
- 4 Nov 2019 Z-0665-2020 Class II Terminated Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
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- 4 Nov 2019 Z-0666-2020 Class II Terminated Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
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- 4 Nov 2019 Z-0665-2020 Class II Terminated Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
2018
- 30 Aug 2018 Z-0208-2019 Class II Terminated The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
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- 30 Aug 2018 Z-0208-2019 Class II Terminated The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
Show the 25 most recent of 92 recalls
2017
- 22 Dec 2017 Z-1749-2018 Class II Terminated Reports of product loosening or coming unscrewed from the handle.
- 31 Aug 2017 Z-0695-2018 Class II Terminated Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
- 12 May 2017 Z-2615-2017 Class II Terminated Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
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- 12 May 2017 Z-2616-2017 Class II Terminated Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
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- 12 May 2017 Z-2617-2017 Class II Terminated Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
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- 12 May 2017 Z-2618-2017 Class II Terminated Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
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- 12 May 2017 Z-2619-2017 Class II Terminated Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
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2015
- 23 Nov 2015 Z-0479-2016 Class II Terminated Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
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- 20 Nov 2015 Z-0656-2016 Class II Terminated Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- 20 Nov 2015 Z-0657-2016 Class II Terminated Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- 20 Nov 2015 Z-0658-2016 Class II Terminated Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- 23 Nov 2015 Z-0479-2016 Class II Terminated Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
2013
- 29 Aug 2013 Z-0191-2014 Class II Terminated Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
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- 29 Aug 2013 Z-0192-2014 Class II Terminated Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
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- 15 Apr 2013 Z-1278-2013 Class II Terminated Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
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- 22 Mar 2013 Z-1172-2013 Class II Terminated The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
- 29 Aug 2013 Z-0191-2014 Class II Terminated Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
Frequently asked questions
How many devices does Depuy Mitek, A Johnson & Johnson Company have in the registry?
The registry currently lists 66 devices for Depuy Mitek, A Johnson & Johnson Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Depuy Mitek, A Johnson & Johnson Company's devices?
Among its 50 most recently registered devices, Depuy Mitek, A Johnson & Johnson Company has devices listed in FDA 510(k) (50 devices).
What risk classes do Depuy Mitek, A Johnson & Johnson Company's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Depuy Mitek, A Johnson & Johnson Company's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Depuy Mitek, A Johnson & Johnson Company?
FDA recall records list 92 recalls initiated by Depuy Mitek, A Johnson & Johnson Company, the most recent initiated on 24 Feb 2025. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Depuy Mitek, A Johnson & Johnson Company in the registry?
The most recently registered devices listed for Depuy Mitek, A Johnson & Johnson Company include OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141, ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE), OMNICUT RESECTION BLADE and DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809.