Mitek Worldwide
Country not established
- Devices
- 10
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Mitek Worldwide makes
Mitek Worldwide manufactures orthopedic fixation devices, including absorbable and non-absorbable suture anchors (e.g., BIOCRYL, BIOFASTIN), tibial screws with sheaths (e.g., BIO-INTRAFIX), and meniscal repair systems (e.g., RAPIDLOC-PDS). Their portfolio also includes tissue management solutions like the EXOJET system, as well as PDS/PGA staples and quick-anchor devices for soft tissue repair.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Mitek Pds/Pga Staple Ref K021953
Regimes: 510(k) Registry: 510(k)Bio-Intrafix Tibial Screw And Sheath Ref K032167
Regimes: 510(k) Registry: 510(k)Biocryl Rapide Interference Screw Ref K032717
Regimes: 510(k) Registry: 510(k)Cufflok Anchor Ref K031519
Regimes: 510(k) Registry: 510(k)Minilok Quickanchor Plus Ref K030995
Regimes: 510(k) Registry: 510(k)Mitek Rapidloc-Pds Meniscal Repair System Ref K023388
Regimes: 510(k) Registry: 510(k)Exojet Tissue Management System Ref K031406
Regimes: 510(k) Registry: 510(k)Microfix Quickanchor Plus Ref K024115
Regimes: 510(k) Registry: 510(k)Biofastin Rc Threaded Suture Anchor Ref K021883
Regimes: 510(k) Registry: 510(k)Mitek Micro Quickanchor Ref K032078
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Mitek Worldwide, the earliest on 2003-02-28 and the most recent on 2003-06-16. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 16 Jun 2003 Z-1004-03 Unclassified (pre-2012) Terminated Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm
- 16 Jun 2003 Z-1005-03 Unclassified (pre-2012) Terminated Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm
- 28 Feb 2003 Z-0696-03 Unclassified (pre-2012) Terminated Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.
- 28 Feb 2003 Z-0697-03 Unclassified (pre-2012) Terminated Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm
- 28 Feb 2003 Z-0698-03 Unclassified (pre-2012) Terminated Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm
- 28 Feb 2003 Z-0699-03 Unclassified (pre-2012) Terminated Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm
Frequently asked questions
How many devices does Mitek Worldwide have in the registry?
The registry currently lists 10 devices for Mitek Worldwide. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitek Worldwide's devices?
Among its 10 most recently registered devices, Mitek Worldwide has devices listed in FDA 510(k) (10 devices).
What risk classes do Mitek Worldwide's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Mitek Worldwide's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mitek Worldwide?
FDA recall records list 6 recalls initiated by Mitek Worldwide, the most recent initiated on 16 Jun 2003. 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 Mitek Worldwide in the registry?
The most recently registered devices listed for Mitek Worldwide include MITEK PDS/PGA STAPLE, BIO-INTRAFIX TIBIAL SCREW AND SHEATH, BIOCRYL RAPIDE INTERFERENCE SCREW and CUFFLOK ANCHOR.