Tag Medical Products
Country not established
- Devices
- 4
- FDA recalls
- 76 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Tag Medical Products makes
Tag Medical Products manufactures orthopedic fixation tools, including cortical screw sets for bone stabilization (e.g., Latarjet screw sets in 36–48mm lengths) and a tissue suspension system for surgical applications. Their portfolio also includes specialized reamer systems for anterior cruciate ligament (ACL) procedures, delivered in sterilized trays for surgical use.
All listed devices fall under Class II regulatory classification in the US, with authorisation via 510(k) clearance through the FDA. The company is based in the United States and its products are registered under the FDA’s 510(k) pathway.
Catalogue
- Regimes: 510(k) Registry: 510(k)
SIIS#1 Tissue Suspension System Ref K020705
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Latarjet Cortical Screw Set Ref K083096
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 7 recalls initiated by Tag Medical Products, the earliest on 2020-01-20 and the most recent on 2023-05-04. By recorded status: 6 ongoing and 1 terminated. The reasons filed fall into these groups: sterility or contamination and mechanical integrity. 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 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 6
- 2024 0
- 2025 0
- 2026 0
2023
- 4 May 2023 Z-2060-2023 Class II Ongoing Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 4 May 2023 Z-2061-2023 Class II Ongoing Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 4 May 2023 Z-2062-2023 Class II Ongoing Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 4 May 2023 Z-2063-2023 Class II Ongoing Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 4 May 2023 Z-2064-2023 Class II Ongoing Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 4 May 2023 Z-2065-2023 Class II Ongoing Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
2020
- 20 Jan 2020 Z-1542-2020 Class II Terminated There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
Full distribution text
- 20 Jan 2020 Z-1542-2020 Class II Terminated There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
Frequently asked questions
How many devices does Tag Medical Products have in the registry?
The registry currently lists 4 devices for Tag Medical Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tag Medical Products's devices?
Among its 4 most recently registered devices, Tag Medical Products has devices listed in FDA 510(k) (4 devices).
What risk classes do Tag Medical Products's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Tag Medical Products's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Tag Medical Products?
FDA recall records list 7 recalls initiated by Tag Medical Products, the most recent initiated on 4 May 2023. 6 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 Tag Medical Products in the registry?
The most recently registered devices listed for Tag Medical Products include MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM), SIIS#1 TISSUE SUSPENSION SYSTEM, VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY and LATARJET CORTICAL SCREW SET.