Betta Link Knotless Long - Implant Only
Model 110045155 · T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · DI 10818674028810
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2023-05-04 | Z-2060-2023 | Class II | Open, Classified | 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. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.67 |
| 2019-02 | 0 | 2.34 |
| 2019-03 | 0 | 3.13 |
| 2019-04 | 0 | 3.17 |
| 2019-05 | 0 | 3.26 |
| 2019-06 | 0 | 2.82 |
| 2019-07 | 0 | 3.81 |
| 2019-08 | 0 | 3.49 |
| 2019-09 | 0 | 3.35 |
| 2019-10 | 0 | 3.19 |
| 2019-11 | 0 | 5.28 |
| 2019-12 | 0 | 5.45 |
| 2020-01 | 0 | 5.46 |
| 2020-02 | 0 | 4.5 |
| 2020-03 | 0 | 3.98 |
| 2020-04 | 0 | 5.42 |
| 2020-05 | 0 | 3.88 |
| 2020-06 | 0 | 3.71 |
| 2020-07 | 0 | 3.74 |
| 2020-08 | 0 | 4.23 |
| 2020-09 | 0 | 4.05 |
| 2020-10 | 0 | 4.53 |
| 2020-11 | 0 | 6.39 |
| 2020-12 | 0 | 5.41 |
| 2021-01 | 0 | 4.74 |
| 2021-02 | 0 | 3.95 |
| 2021-03 | 0 | 3.83 |
| 2021-04 | 0 | 3.82 |
| 2021-05 | 0 | 4.06 |
| 2021-06 | 0 | 4.11 |
| 2021-07 | 0 | 4 |
| 2021-08 | 0 | 4.46 |
| 2021-09 | 0 | 4.05 |
| 2021-10 | 0 | 4.44 |
| 2021-11 | 0 | 4.37 |
| 2021-12 | 0 | 4.43 |
| 2022-01 | 0 | 4 |
| 2022-02 | 0 | 3.37 |
| 2022-03 | 0 | 3.88 |
| 2022-04 | 0 | 3.8 |
| 2022-05 | 0 | 4.06 |
| 2022-06 | 0 | 3.85 |
| 2022-07 | 0 | 3.56 |
| 2022-08 | 0 | 4.39 |
| 2022-09 | 0 | 3.86 |
| 2022-10 | 0 | 4.15 |
| 2022-11 | 0 | 2.87 |
| 2022-12 | 0 | 3.93 |
| 2023-01 | 0 | 3.27 |
| 2023-02 | 0 | 3.2 |
| 2023-03 | 0 | 3.8 |
| 2023-04 | 0 | 4.26 |
| 2023-05 | 0 | 4.67 |
| 2023-06 | 0 | 4.2 |
| 2023-07 | 0 | 3.85 |
| 2023-08 | 0 | 4.49 |
| 2023-09 | 0 | 4.47 |
| 2023-10 | 0 | 4.71 |
| 2023-11 | 0 | 4.63 |
| 2023-12 | 0 | 5.49 |
| 2024-01 | 0 | 5.56 |
| 2024-02 | 0 | 4.93 |
| 2024-03 | 0 | 4.78 |
| 2024-04 | 0 | 5.43 |
| 2024-05 | 0 | 6.48 |
| 2024-06 | 0 | 7.52 |
| 2024-07 | 0 | 4.11 |
| 2024-08 | 0 | 4.21 |
| 2024-09 | 0 | 5 |
| 2024-10 | 0 | 4.7 |
| 2024-11 | 0 | 4.41 |
| 2024-12 | 0 | 4.25 |
| 2025-01 | 0 | 5.12 |
| 2025-02 | 0 | 4.81 |
| 2025-03 | 0 | 4.57 |
| 2025-04 | 0 | 4.98 |
| 2025-05 | 0 | 5.81 |
| 2025-06 | 0 | 5.47 |
| 2025-07 | 0 | 5.19 |
| 2025-08 | 0 | 5.08 |
| 2025-09 | 0 | 4.29 |
| 2025-10 | 0 | 4.62 |
| 2025-11 | 0 | 5.25 |
| 2025-12 | 0 | 6.07 |
| 2026-01 | 0 | 5.06 |
| 2026-02 | 0 | 5.39 |
| 2026-03 | 0 | 5.98 |
| 2026-04 | 0 | 5.93 |
| 2026-05 | 0 | 5.88 |
| 2026-06 | 0 | 6.16 |
Regulatory clearances
- K210498 SESE 2021-03-24 (k number procode)
Predicate lineage
K210498 — cites (transitively): K113297 (d1), K122314 (d1), K190125 (d1), K070882 (d2), K093428 (d2), K093897 (d2), K111564 (d2), K121861 (d2), K132043 (d2), K943949 (d2), K051219 (d3), K073509 (d3), K061776 (d3), K041216 (d3), K072332 (d3), K092508 (d3), K073149 (d3), K002261 (d4)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
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