GAATON, N/A, Israel
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. recalls
2 recalls recorded since 2018, most recently on 4 May 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 May 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2065-2023, Z-2062-2023, Z-2061-2023, Z-2064-2023, Z-2060-2023, Z-2063-2023
- Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045157
- BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045150
- BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045160
- Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045156
- BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154
- BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045151
Terminated Class II Medical devices
- Recall started
- 20 January 2020
- Terminated
- 21 April 2025
- Reason
- 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.
- Distribution
- Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1542-2020
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.