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LUPINE ORTHOCORD
Model 210711 · Medos International Sàrl · DI 10886705001095
GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid · Class II · 21 CFR 878.4493
GAS — Suture, Nonabsorbable, Synthetic, Polyester · Class II · 21 CFR 878.5000
GAT — Suture, Nonabsorbable, Synthetic, Polyethylene · Class II · 21 CFR 878.5000
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (20)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2023-04-13 | Z-1677-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | k number procode |
| 2023-04-13 | Z-1680-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | k number procode |
| 2023-04-13 | Z-1679-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | k number procode |
| 2023-04-13 | Z-1678-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | k number procode |
| 2023-04-13 | Z-1681-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | k number procode |
| 2012-01-27 | Z-1166-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1168-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1169-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1170-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1171-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1167-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1162-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1163-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1164-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2012-01-27 | Z-1165-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | k number procode | |
| 2011-10-31 | Z-0314-2012 | Terminated | Incorrect suture configuration | k number procode | |
| 2011-10-31 | Z-0318-2012 | Terminated | Incorrect suture configuration | k number procode | |
| 2011-10-31 | Z-0317-2012 | Terminated | Incorrect suture configuration | k number procode | |
| 2011-10-31 | Z-0316-2012 | Terminated | Incorrect suture configuration | k number procode | |
| 2011-10-31 | Z-0315-2012 | Terminated | Incorrect suture configuration | k number procode |
Adverse-event reports — MAUDE (43)
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.
Malfunction: 40 · Injury: 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.23 |
| 2019-02 | 0 | 2.79 |
| 2019-03 | 0 | 2.8 |
| 2019-04 | 0 | 2.98 |
| 2019-05 | 2 | 3.2 |
| 2019-06 | 0 | 2.94 |
| 2019-07 | 0 | 3.13 |
| 2019-08 | 0 | 3.06 |
| 2019-09 | 1 | 3.44 |
| 2019-10 | 0 | 3.03 |
| 2019-11 | 0 | 3.71 |
| 2019-12 | 1 | 3.65 |
| 2020-01 | 0 | 4 |
| 2020-02 | 1 | 3.39 |
| 2020-03 | 1 | 3.91 |
| 2020-04 | 0 | 5.12 |
| 2020-05 | 0 | 3.66 |
| 2020-06 | 0 | 3.25 |
| 2020-07 | 1 | 4.33 |
| 2020-08 | 0 | 3.84 |
| 2020-09 | 1 | 3.96 |
| 2020-10 | 0 | 4.2 |
| 2020-11 | 0 | 4.71 |
| 2020-12 | 0 | 4.79 |
| 2021-01 | 0 | 5.04 |
| 2021-02 | 2 | 4.31 |
| 2021-03 | 1 | 4.23 |
| 2021-04 | 1 | 4.36 |
| 2021-05 | 0 | 4.5 |
| 2021-06 | 2 | 3.89 |
| 2021-07 | 1 | 4.62 |
| 2021-08 | 0 | 4.14 |
| 2021-09 | 0 | 4.68 |
| 2021-10 | 0 | 4.31 |
| 2021-11 | 0 | 4.32 |
| 2021-12 | 1 | 4.68 |
| 2022-01 | 1 | 4.29 |
| 2022-02 | 0 | 3.95 |
| 2022-03 | 0 | 4.39 |
| 2022-04 | 0 | 4.3 |
| 2022-05 | 0 | 4.41 |
| 2022-06 | 1 | 3.8 |
| 2022-07 | 1 | 3.97 |
| 2022-08 | 4 | 5.43 |
| 2022-09 | 0 | 4.83 |
| 2022-10 | 6 | 4.67 |
| 2022-11 | 3 | 4.75 |
| 2022-12 | 3 | 5.29 |
| 2023-01 | 1 | 5.11 |
| 2023-02 | 0 | 5.21 |
| 2023-03 | 0 | 5.71 |
| 2023-04 | 0 | 5.68 |
| 2023-05 | 1 | 5.69 |
| 2023-06 | 0 | 6.17 |
| 2023-07 | 0 | 5.3 |
| 2023-08 | 0 | 5.79 |
| 2023-09 | 0 | 5.16 |
| 2023-10 | 0 | 5.38 |
| 2023-11 | 1 | 4.64 |
| 2023-12 | 0 | 5.98 |
| 2024-01 | 0 | 5.1 |
| 2024-02 | 0 | 5.72 |
| 2024-03 | 1 | 7.95 |
| 2024-04 | 1 | 12 |
| 2024-05 | 0 | 11.96 |
| 2024-06 | 0 | 12.99 |
| 2024-07 | 0 | 11.47 |
| 2024-08 | 0 | 7.32 |
| 2024-09 | 0 | 7.17 |
| 2024-10 | 1 | 5.21 |
| 2024-11 | 1 | 5.33 |
| 2024-12 | 0 | 4.98 |
| 2025-01 | 0 | 5.73 |
| 2025-02 | 0 | 4.62 |
| 2025-03 | 1 | 4.91 |
| 2025-04 | 0 | 5.44 |
| 2025-05 | 0 | 5.39 |
| 2025-06 | 0 | 5.39 |
| 2025-07 | 0 | 4.81 |
| 2025-08 | 0 | 4.89 |
| 2025-09 | 0 | 4.43 |
| 2025-10 | 0 | 4.65 |
| 2025-11 | 0 | 5.79 |
| 2025-12 | 0 | 6.04 |
| 2026-01 | 0 | 5.49 |
| 2026-02 | 0 | 6.01 |
| 2026-03 | 0 | 5.26 |
| 2026-04 | 0 | 5.32 |
| 2026-05 | 0 | 6.02 |
| 2026-06 | 0 | 6.2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K070925 — cited as predicate by K101459, K123393, K183501
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl
Nothing in the loaded window.