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CinchLock

Model CAT02462 · STRYKER CORPORATION · DI 07613252633228

MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (2)

InitiatedRecall #ClassStatusReasonLink basis
2023-08-23Z-2645-2023Class IIOpen, ClassifiedExpired Product distributedk number procode
2016-04-12Z-1634-2016Class IITerminatedStryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.k number procode

Adverse-event reports — MAUDE (112)

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: 100 · Injury: 12

61319252019-01: 1 reports for this device; peer average 4.67/device2019-02: 1 reports for this device; peer average 2.34/device2019-03: 0 reports for this device; peer average 3.13/device2019-04: 1 reports for this device; peer average 3.17/device2019-05: 1 reports for this device; peer average 3.26/device2019-06: 0 reports for this device; peer average 2.82/device2019-07: 1 reports for this device; peer average 3.81/device2019-08: 0 reports for this device; peer average 3.49/device2019-09: 0 reports for this device; peer average 3.35/device2019-10: 0 reports for this device; peer average 3.19/device2019-11: 0 reports for this device; peer average 5.28/device2019-12: 2 reports for this device; peer average 5.45/device2020-01: 3 reports for this device; peer average 5.46/device2020-02: 1 reports for this device; peer average 4.5/device2020-03: 0 reports for this device; peer average 3.98/device2020-04: 0 reports for this device; peer average 5.42/device2020-05: 0 reports for this device; peer average 3.88/device2020-06: 1 reports for this device; peer average 3.71/device2020-07: 0 reports for this device; peer average 3.74/device2020-08: 0 reports for this device; peer average 4.23/device2020-09: 0 reports for this device; peer average 4.05/device2020-10: 1 reports for this device; peer average 4.53/device2020-11: 0 reports for this device; peer average 6.39/device2020-12: 0 reports for this device; peer average 5.41/device2021-01: 0 reports for this device; peer average 4.74/device2021-02: 3 reports for this device; peer average 3.95/device2021-03: 3 reports for this device; peer average 3.83/device2021-04: 0 reports for this device; peer average 3.82/device2021-05: 2 reports for this device; peer average 4.06/device2021-06: 4 reports for this device; peer average 4.11/device2021-07: 0 reports for this device; peer average 4/device2021-08: 1 reports for this device; peer average 4.46/device2021-09: 0 reports for this device; peer average 4.05/device2021-10: 2 reports for this device; peer average 4.44/device2021-11: 1 reports for this device; peer average 4.37/device2021-12: 0 reports for this device; peer average 4.43/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 3.37/device2022-03: 0 reports for this device; peer average 3.88/device2022-04: 0 reports for this device; peer average 3.8/device2022-05: 0 reports for this device; peer average 4.06/device2022-06: 0 reports for this device; peer average 3.85/device2022-07: 0 reports for this device; peer average 3.56/device2022-08: 0 reports for this device; peer average 4.39/device2022-09: 0 reports for this device; peer average 3.86/device2022-10: 2 reports for this device; peer average 4.15/device2022-11: 0 reports for this device; peer average 2.87/device2022-12: 1 reports for this device; peer average 3.93/device2023-01: 0 reports for this device; peer average 3.27/device2023-02: 0 reports for this device; peer average 3.2/device2023-03: 0 reports for this device; peer average 3.8/device2023-04: 2 reports for this device; peer average 4.26/device2023-05: 25 reports for this device; peer average 4.67/device2023-06: 0 reports for this device; peer average 4.2/device2023-07: 1 reports for this device; peer average 3.85/device2023-08: 2 reports for this device; peer average 4.49/device2023-09: 2 reports for this device; peer average 4.47/device2023-10: 0 reports for this device; peer average 4.71/device2023-11: 3 reports for this device; peer average 4.63/device2023-12: 0 reports for this device; peer average 5.49/device2024-01: 0 reports for this device; peer average 5.56/device2024-02: 0 reports for this device; peer average 4.93/device2024-03: 0 reports for this device; peer average 4.78/device2024-04: 0 reports for this device; peer average 5.43/device2024-05: 0 reports for this device; peer average 6.48/device2024-06: 0 reports for this device; peer average 7.52/device2024-07: 0 reports for this device; peer average 4.11/device2024-08: 0 reports for this device; peer average 4.21/device2024-09: 1 reports for this device; peer average 5/device2024-10: 1 reports for this device; peer average 4.7/device2024-11: 1 reports for this device; peer average 4.41/device2024-12: 4 reports for this device; peer average 4.25/device2025-01: 0 reports for this device; peer average 5.12/device2025-02: 2 reports for this device; peer average 4.81/device2025-03: 13 reports for this device; peer average 4.57/device2025-04: 13 reports for this device; peer average 4.98/device2025-05: 0 reports for this device; peer average 5.81/device2025-06: 1 reports for this device; peer average 5.47/device2025-07: 1 reports for this device; peer average 5.19/device2025-08: 0 reports for this device; peer average 5.08/device2025-09: 2 reports for this device; peer average 4.29/device2025-10: 1 reports for this device; peer average 4.62/device2025-11: 0 reports for this device; peer average 5.25/device2025-12: 1 reports for this device; peer average 6.07/device2026-01: 0 reports for this device; peer average 5.06/device2026-02: 0 reports for this device; peer average 5.39/device2026-03: 1 reports for this device; peer average 5.98/device2026-04: 0 reports for this device; peer average 5.93/device2026-05: 1 reports for this device; peer average 5.88/device2026-06: 2 reports for this device; peer average 6.16/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0114.67
2019-0212.34
2019-0303.13
2019-0413.17
2019-0513.26
2019-0602.82
2019-0713.81
2019-0803.49
2019-0903.35
2019-1003.19
2019-1105.28
2019-1225.45
2020-0135.46
2020-0214.5
2020-0303.98
2020-0405.42
2020-0503.88
2020-0613.71
2020-0703.74
2020-0804.23
2020-0904.05
2020-1014.53
2020-1106.39
2020-1205.41
2021-0104.74
2021-0233.95
2021-0333.83
2021-0403.82
2021-0524.06
2021-0644.11
2021-0704
2021-0814.46
2021-0904.05
2021-1024.44
2021-1114.37
2021-1204.43
2022-0104
2022-0203.37
2022-0303.88
2022-0403.8
2022-0504.06
2022-0603.85
2022-0703.56
2022-0804.39
2022-0903.86
2022-1024.15
2022-1102.87
2022-1213.93
2023-0103.27
2023-0203.2
2023-0303.8
2023-0424.26
2023-05254.67
2023-0604.2
2023-0713.85
2023-0824.49
2023-0924.47
2023-1004.71
2023-1134.63
2023-1205.49
2024-0105.56
2024-0204.93
2024-0304.78
2024-0405.43
2024-0506.48
2024-0607.52
2024-0704.11
2024-0804.21
2024-0915
2024-1014.7
2024-1114.41
2024-1244.25
2025-0105.12
2025-0224.81
2025-03134.57
2025-04134.98
2025-0505.81
2025-0615.47
2025-0715.19
2025-0805.08
2025-0924.29
2025-1014.62
2025-1105.25
2025-1216.07
2026-0105.06
2026-0205.39
2026-0315.98
2026-0405.93
2026-0515.88
2026-0626.16
This device (reports/month)Average device in MBI (reports/device/month)

Regulatory clearances

  • K131769 SESE 2013-10-07 (k number procode)

Predicate lineage

K131769 — cites (transitively): K071586 (d1), K123651 (d1), K130351 (d1), K093428 (d2) — cited as predicate by K173074, K180361

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations