Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.13 |
| 2019-02 | 0 | 2.1 |
| 2019-03 | 0 | 2.9 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 2.86 |
| 2019-06 | 0 | 2.59 |
| 2019-07 | 0 | 3.24 |
| 2019-08 | 0 | 2.96 |
| 2019-09 | 0 | 3.2 |
| 2019-10 | 3 | 3.04 |
| 2019-11 | 0 | 4.34 |
| 2019-12 | 1 | 4.49 |
| 2020-01 | 0 | 4.46 |
| 2020-02 | 0 | 3.89 |
| 2020-03 | 0 | 3.58 |
| 2020-04 | 0 | 4.87 |
| 2020-05 | 0 | 3.38 |
| 2020-06 | 0 | 3.53 |
| 2020-07 | 0 | 3.27 |
| 2020-08 | 0 | 3.89 |
| 2020-09 | 0 | 3.62 |
| 2020-10 | 0 | 4.03 |
| 2020-11 | 0 | 5.44 |
| 2020-12 | 0 | 4.74 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 0 | 3.69 |
| 2021-03 | 0 | 3.53 |
| 2021-04 | 1 | 3.41 |
| 2021-05 | 0 | 3.89 |
| 2021-06 | 0 | 3.83 |
| 2021-07 | 0 | 3.6 |
| 2021-08 | 0 | 3.87 |
| 2021-09 | 0 | 3.87 |
| 2021-10 | 0 | 3.99 |
| 2021-11 | 0 | 4.2 |
| 2021-12 | 0 | 4.04 |
| 2022-01 | 2 | 3.82 |
| 2022-02 | 0 | 3.26 |
| 2022-03 | 0 | 3.71 |
| 2022-04 | 0 | 3.61 |
| 2022-05 | 0 | 3.65 |
| 2022-06 | 0 | 3.53 |
| 2022-07 | 0 | 3.37 |
| 2022-08 | 2 | 4.16 |
| 2022-09 | 2 | 3.66 |
| 2022-10 | 0 | 4.25 |
| 2022-11 | 1 | 2.78 |
| 2022-12 | 0 | 3.64 |
| 2023-01 | 0 | 3.47 |
| 2023-02 | 1 | 3.05 |
| 2023-03 | 0 | 3.7 |
| 2023-04 | 0 | 4.01 |
| 2023-05 | 0 | 4.38 |
| 2023-06 | 0 | 4.35 |
| 2023-07 | 0 | 3.52 |
| 2023-08 | 0 | 4.08 |
| 2023-09 | 0 | 4.3 |
| 2023-10 | 0 | 4.29 |
| 2023-11 | 0 | 4.33 |
| 2023-12 | 0 | 5.06 |
| 2024-01 | 0 | 5.15 |
| 2024-02 | 0 | 4.52 |
| 2024-03 | 0 | 4.4 |
| 2024-04 | 0 | 4.78 |
| 2024-05 | 1 | 5.85 |
| 2024-06 | 0 | 6.97 |
| 2024-07 | 0 | 3.86 |
| 2024-08 | 0 | 4.14 |
| 2024-09 | 0 | 4.74 |
| 2024-10 | 2 | 4.36 |
| 2024-11 | 0 | 4.26 |
| 2024-12 | 0 | 4.11 |
| 2025-01 | 0 | 4.98 |
| 2025-02 | 0 | 4.47 |
| 2025-03 | 3 | 4.27 |
| 2025-04 | 0 | 4.65 |
| 2025-05 | 1 | 5.22 |
| 2025-06 | 2 | 5.06 |
| 2025-07 | 0 | 4.88 |
| 2025-08 | 0 | 4.82 |
| 2025-09 | 0 | 4.25 |
| 2025-10 | 0 | 4.53 |
| 2025-11 | 0 | 5.05 |
| 2025-12 | 0 | 5.73 |
| 2026-01 | 2 | 4.89 |
| 2026-02 | 0 | 5.3 |
| 2026-03 | 0 | 5.66 |
| 2026-04 | 0 | 5.42 |
| 2026-05 | 0 | 6.15 |
| 2026-06 | 0 | 5.99 |
24 linked report narratives available — no AI summary generated yet.
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2017-08-22 | Z-0818-2018 | Class II | Terminated | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.Distribution: Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS. | 885 units total | code info di |
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-01-30 | 0001825034-2026-00259 | Malfunction | Available | exact di |
| 2026-01-30 | 0001825034-2026-00258 | Malfunction | Available | exact di |
| 2025-06-10 | 0001825034-2025-01674 | Malfunction | Available | exact di |
| 2025-06-10 | 0001825034-2025-01673 | Malfunction | Available | exact di |
| 2025-05-15 | 0001825034-2025-01418 | Malfunction | Available | exact di |
| 2025-03-10 | 0001825034-2025-00616 | Malfunction | Available | exact di |
| 2025-03-10 | 0001825034-2025-00617 | Malfunction | Available | exact di |
| 2025-03-10 | 0001825034-2025-00618 | Malfunction | Available | exact di |
| 2024-10-23 | 0001825034-2024-02501 | Malfunction | Available | exact di |
| 2024-10-23 | 0001825034-2024-02502 | Malfunction | Available | exact di |
| 2024-05-17 | 0001825034-2024-01271 | Malfunction | Available | exact di |
| 2023-02-28 | 0001825034-2022-02157 | Malfunction | Available | exact di |
| 2022-11-28 | 0001825034-2022-02675 | Malfunction | Available | exact di |
| 2022-09-16 | 0001825034-2022-01705 | Malfunction | Available | exact di |
| 2022-09-16 | 0001825034-2022-02154 | Malfunction | Available | exact di |
Predicate lineage
Cited as predicate by: K123341, K130033, K131850, K133606, K133858, K140324, K143092, K153186, K162996, K170249, K181086, K220260
Cited as predicate by: K133606, K140324, K141263, K151004, K153186, K170440, K173278, K200028, K203121, K211770, K220260, K220650, K231857, K233531, K242091
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- Container FOURNITURES HOSPITALIERES INDUSTRIE
- Pin guide cannula FOURNITURES HOSPITALIERES INDUSTRIE
- 10mm x 10mm Staple System Trilliant Surgical, LLC
- 10mm x 10mm x 10mm Staple Trilliant Surgical, LLC
- 12mm STEP STAPLE 15X20-2X2 BIOPRO, INC.
- 12mm STEP STAPLE 20X20-2X3 BIOPRO, INC.
- 12mm x 12mm x 12mm Staple Trilliant Surgical, LLC
- 15mm x 12mm x 12mm Staple Trilliant Surgical, LLC
- 15mm x 15mm x 15mm Staple Trilliant Surgical, LLC
- 18mm x 15mm x 15mm Staple Trilliant Surgical, LLC
- 18mm x 18mm x 18mm Staple Trilliant Surgical, LLC
- 2.9 X 12.5mm Citrefix XPress System Acuitive Technologies, Inc.