CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report
Betta Link LG Reusable Fishmouth Guide-Intended for use recalled
T.A.G. Medical Products is recalling Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation, distributed nationwide in the US. The recall was initiated on 4 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2065-2023
- FDA event ID
- 92410
- Recalling firm
- T.A.G. Medical Products, GAATON, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 May 2023
- FDA classified
- 3 Jul 2023
- Reported
- 12 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 4 May 2023 | Recall initiated by company | |
| 3 Jul 2023 | Classified by FDA | +60 days |
| 12 Jul 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 10818674025833 Lot Numbers: 22A01, 22C01, 22F01
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 92410| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Betta Link SR Reusable Pronged Guide- Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide | |
| CLASS II | Betta Link LG Knotless Implant Kit-Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide | |
| CLASS II | Betta Link LG Reusable ProngED Guide - Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide | |
| CLASS II | Betta Link SR Knotless Implant Kit-Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide | |
| CLASS II | Betta Link SR Reusable Fishmouth Guide-Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide |
More recalls from T.A.G. Medical Products
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Betta Link SR Reusable Fishmouth Guide-Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide |
| Device | CLASS II | Betta Link SR Knotless Implant Kit-Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide |
| Device | CLASS II | Betta Link LG Reusable ProngED Guide - Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide |
| Device | CLASS II | Betta Link LG Knotless Implant Kit-Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide |
| Device | CLASS II | Betta Link SR Reusable Pronged Guide- Intended for use recalled | T.A.G. Medical Products | Foreign Material | Nationwide |
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