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INFUSE® Bone Graft

Model 7510200 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00681490843782

NEK — Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction · Class III

NPZ — Bone Grafting Material, Dental, With Biologic Component · Class III · 21 CFR 872.3930

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (8)

InitiatedRecall #ClassStatusReasonLink basis
2018-09-27Z-0440-2019Class IITerminatedThe Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.k number procode
2013-05-28Z-1590-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode
2013-05-28Z-1591-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode
2013-05-28Z-1592-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode
2013-05-28Z-1589-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode
2013-05-28Z-1594-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode
2013-05-28Z-1595-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode
2013-05-28Z-1593-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.k number procode

Adverse-event reports — MAUDE (14)

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.

Injury: 14

12342019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 2 reports for this device; peer average 2/device2019-07: 2 reports for this device; peer average 1.5/device2019-08: 2 reports for this device; peer average 1.5/device2020-01: 2 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-08: 2 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 4/device2022-07: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2023-10: 2 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 2/device2026-06: 2 reports for this device; peer average 2/device0204050708010208091002030901071010030607040708091001030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0401
2019-0522
2019-0721.5
2019-0821.5
2020-0122
2020-0201
2020-0822
2020-0903
2020-1003
2021-0202
2021-0301.5
2021-0902
2022-0104
2022-0702
2022-1002
2023-1022
2024-0302
2024-0602
2024-0702
2025-0402
2025-0701
2025-0801
2025-0902
2025-1003
2026-0101
2026-0303
2026-0502
2026-0622
This device (reports/month)Average device in NEK, NPZ (reports/device/month)

Regulatory clearances

  • P000058 APPR 2026-07-28 (k number procode)
  • P000058 OK30 2026-03-19 (k number procode)
  • P000058 OK30 2026-02-24 (k number procode)
  • P000058 APPR 2026-02-13 (k number procode)
  • P000058 OK30 2025-03-19 (k number procode)
  • P000058 OK30 2024-11-06 (k number procode)
  • P000058 OK30 2023-10-06 (k number procode)
  • P000058 APPR 2023-08-25 (k number procode)
  • P000058 OK30 2023-08-21 (k number procode)
  • P000058 OK30 2023-08-21 (k number procode)
  • P000058 OK30 2022-08-09 (k number procode)
  • P000058 OK30 2022-06-08 (k number procode)
  • P000058 APPR 2022-02-18 (k number procode)
  • P000058 OK30 2022-02-17 (k number procode)
  • P000058 APPR 2021-11-08 (k number procode)
  • P000058 OK30 2021-04-05 (k number procode)
  • P000058 OK30 2021-02-05 (k number procode)
  • P000058 APPR 2020-12-30 (k number procode)
  • P000058 OK30 2020-08-27 (k number procode)
  • P000058 OK30 2020-07-10 (k number procode)

Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.

  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2017-10-26 Medtronic Sofamor Danek USA, Inc · 0 citations
  • VAI 2015-11-03 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2015-10-23 Medtronic Sofamor Danek USA Inc · 1 citations
  • VAI 2014-03-11 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA, Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2012-06-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2011-02-23 Medtronic Sofamor Danek Usa Inc · 0 citations
  • VAI 2010-08-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2010-03-04 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2010-02-25 Medtronic Sofamor Danek USA Inc · 0 citations