INFUSE® Bone Graft 7510100Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994239525), received between Nov 17, 2016 and Sep 18, 2026 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (P000058, P050053); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 27, 2018Class IITerminated

   The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

   Z-0440-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Clinical Study) regarding a Patient with CLinical ID: (b)(6) and study ID: MDT22045C STAIL It was reported that the patient had 3/5 Foot Drop, Right Foot. Interventions: NA Outcome Status: Not Recovered/ Not Resolved On August 20, 2026, a neurological exam was performed and showed right foot drop with 3/5 strength and numbness in the right shin, both of which were considered clinically significant. Site Seriousness Assessment: NA Sponsor Assessment (OC MUO): Sponsor assessed as possible related to index procedure and possible related to device. Update Received on 16-Sep-2026: Site Related Assessment: assessed as not related to study device.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 50813821 ↗
• InjuryOct 27, 2025Off-Label Use; Off-Label Use

  2025 NOV 7, UPDATE RECEIVED, ONSET DATE, OUTCOME, OUTCOME DATE FOR THE EVENT OF CHRONIC PAIN IN NECK/ARM. ONSET DATE: 11/2014 OUTCOME: REPEAT SURGERY OUTCOME DATE: (B)(6) 2015, ONSET DATE, OUTCOME, OUTCOME DATE, SEVERITY FOR THE EVENTS OF NUMBNESS IN RIGHT HAND, NUMBNESS IN RIGHT THUMB, POINTER AND MIDDLE FINGER AND FORAMINAL STENOSIS. ONSET DATE: 11/2014 OUTCOME: REPEAT SURGERY OUTCOME DATE: (B)(6) 2015.

  Patient problems: Extraskeletal ossification; Numbness; Pain; Stenosis

  MAUDE report 23389043 ↗
• InjuryOct 22, 2025Off-Label Use; Off-Label Use

  INFORMATION WAS RECEIVED FROM CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT EXPERIENCING CHRONIC PAIN AND REQUIRING ADDITIONAL SURGERY DUE TO ECTOPIC BONE GROWTH FOLLOWING THE IMPLANTATION OF MEDTRONIC INFUSE BONE GRAFT IN THE CERVICAL SPINE DURING SURGERY PERFORMED ON JULY 14, 2015. THE PATIENT WAS NOT NOTIFIED OF KNOWN RISKS, FDA WARNINGS, OR LEGAL ACTIONS RELATED TO THE OFF-LABEL USE OF INFUSE IN THE CERVICAL REGION, AND ONLY RECENTLY BECAME AWARE OF THESE ISSUES AFTER ONGOING HEALTH COMPLICATIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFUSE WAS USED ON (B)(6) 2014 AT C5/6. THE ADDITIONAL SURGERY TO REMOVE ECTOPIC BONE GROWTH WAS (B)(6) 2015. BOTH SURGERIES WERE DONE AT CEDARS SINAI BY ELI BARON. THE DECISION TO USE INFUSE IN NECK WAS MADE BY SURGEON.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 23357950 ↗
• MalfunctionJun 14, 2024Osseointegration Problem; Osseointegration Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND CLINICAL STUDY NAME ALLIANCE IMPLANTED WITH INFUSE HAVING SPINAL FUSION THERAPY. IT WAS REPORTED DURING 6 MONTH VISIT THAT THERE WAS PROBABLE SIGNIFICANT RESORPTION OF THE BONE GRAFT DUE TO PSEUDOARTHROSIS, MAJOR LUCENCY, OR GAP VISIBLE IN FUSION AREA (2MM AROUND THE ENTIRE PERIPHERY OF GRAFT). THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT NO HOSPITALIZATION OR ADDITIONAL SURGERY WERE REPORTED FOR THE PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19535674 ↗
• MalfunctionMar 19, 2024Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, RISK MANAGER) REGARDING A PATIENT WHO WAS IMPLANTED WITH INFUSE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN EXPIRED INFUSE PRODUCT. DATE OF SURGERY WAS (B)(6) 2024. OPERATION PERFORMED WAS C1-2-3-4 POSTERIOR ARTHRODESIS AND BMP WAS PLACED AT C12. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928533 ↗
• InjuryOct 13, 2022Break; Loose or Intermittent Connection

  (B)(6) 2019: DISCOVER MEDTRONIC TITANIUM PEDICLE SCREW AT L4, SCREW HEAD BROKE OFF AND SCREW HEAD LODGED INTO MUSCLE. TWO DIFFERENT NEUROSURGEONS CALL IT PSEUDARTHROSIS OR FAILED BACK SURGERY. (B)(6) 2022: DISCOVER ON MY OWN FDA RECALL REF 7510050. WHAT IS THE REASON FOR WHY NO ONE WOULD CONTACT ME ABOUT THE RECALL? (B)(6) 2022: REVISION SURGERY RESCHEDULED UNTIL CT SCAN COMPLETED. (CT SCAN COMPLETED ON (B)(6) 2022). (B)(6) 2022: APPOINTMENT WITH DR. (B)(6) NEUROSURGEON A REVIEW OF MRI AND CT SCAN IMAGES; DR. (B)(6) SAID THERE IS VERY LITTLE BONE GROWTH ON THE LEFT SIDE FROM L4 DOWN TO S1, THAT'S NOT GOOD. MRI SHOWS PRESSURE BETWEEN L3-L4 ON THE RIGHT SIDE. CT SCAN SHOWS DISLODGED BONE OR BONE-SPUR GROWTH AT L4 CAUSING PRESSURE ON THE NERVES ON THE LEFT SIDE. REVISION SURGERY SCHEDULED FOR (B)(6) 2022. PLEASE SEE OTHER RELEVANT HISTORY FOR DETAILED EXPLANATION. I HAVE SUPPORTING DOCUMENTS AND MRI, CT, AND X-RAY IMAGES ON DISC. OTHER RELEVANT HISTORY: (B)(6) 2017: I MET WITH (B)(6), M.D. TO REVIEW MRI AND DISCUSS SURGERY OPTION. I CHOOSE DR. (B)(6) FOR HIS MINIMAL INVASIVE APPROACH AND 1.5 HOURS IN SURGERY. I HAD SEEN DR. (B)(6) FOR THIS SURGERY AND HIS TIME UNDER THE KNIFE WAS 6 HO

  Patient problems: Anxiety; Chest Pain; Concussion; Dizziness; Foreign Body In Patient; Ischemia Stroke; Malunion of Bone; Sleep Dysfunction

  MAUDE report 15606103 ↗
• InjuryOct 3, 2022Break; Entrapment of Device; Nonstandard Device

  MAJOR LIFE CHANGING EVENT STARTED AFTER 2 STAGE SPINAL FUSION ((B)(6) 2017). (B)(6) 2019: DISCOVER MEDTRONIC TITANIUM PEDICLE SCREW AT L4, SCREW HEAD BROKE OFF AND SCREW HEAD LODGED INTO MUSCLE. TWO DIFFERENT NEUROSURGEONS CALL IT PSEUDARTHROSIS OR FAILED BACK SURGERY. (B)(6) 2022: DISCOVER ON MY OWN FDA RECALL REF 7510050. WHAT IS THE REASON FOR WHY NO ONE WOULD CONTACT ME ABOUT THE RECALL? (B)(6) 2022: REVISION SURGERY RESCHEDULED UNTIL CT SCAN COMPLETED. (CT SCAN COMPLETED ON (B)(6) 2022). (B)(6) 2022: OFFICE VISIT WITH DR (B)(6) TO REVIEW ALL IMAGES, DEVELOPE SURGERY PLAN, AND SCHEDULE REVISION SURGERY. PLEASE SEE OTHER RELEVANT HISTORY FOR DETAILED EXPLANATION.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 15537063 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L5-S1 DUE TO DEGENERATIVE DISC DISEASE. POST-OP, THE PATIENT SUFFERED FROM DRAMATIC INFLAMMATORY RESPONSE AND PAIN. THE IMPLANT WAS PLACED POSTEROLATERALLY.

  Patient problems: Inflammation; Pain

  MAUDE report 9768046 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: LUMBAR SPONDYLOSIS. HE UNDERWENT FOLLOWING PROCEDURE: ANTERIOR LUMBAR INTERBODY FUSION. NO INTRA OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7500154 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L5-S1 STENOSIS/SPONDYLOSIS AND UNDERWENT L5-S1 DECOMPRESSIVE POSTERIOR LUMBAR INTERBODY FUSION IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7330029 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Injury

  MAUDE report 7141517 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY AND FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7120452 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT UNDERWENT FOLLOWING PROCEDURES: LEFT L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION USING PEEK SPACER, AND AUTOGRAFT. POSTERIOR INSTRUMENTATION WITH PEDICLE SCREWS AND POSTEROLATERAL FUSION WITH AUTOGRAFT, ALLOGRAFT, AND BMP-2. PREOPERATIVE DIAGNOSIS: L4-5 DEGENERATIVE DISC. LEFT L4-5 STENOSIS. AS PER OP NOTES: ¿NEXT, A 12MM GRAFT WAS PACKED WITH MORCELLIZED FIT SNUGLY. MORCELLIZED AUTOGRAFT WAS THEN PACKED MEDIAL AND LATERAL TO THE SPACER. NEXT, ATTENTION WAS TURNED TOWARD THE FACET JOINT ON THE RIGHT. THIS WAS DECORTICATED AND PACKED WITH MORCELLIZED AUTOGRAFT AS WELL AS BMP-2 AUTOGRAFT, A LITTLE BIT OF ALLOGRAFT, AND BMP-2 SPONGE. ON THE LEFT HAND SIDE, THE LATERAL RECESS WAS DECORTICATED AND PACKED WITH MORCELLIZED ALLOGRAFT.¿. POST OPERATIVELY THE PATIENT REPORTED DISC HERNIATION AND UNDERWENT A REVISION SURGERY IN (B)(6) 2011.

  Patient problems: No Code Available

  MAUDE report 6649472 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT UNDERWENT A SPINAL SURGERY IN WHICH RHBMP-2 WAS IMPLANTED AT L5-S1. POST OPERATIVELY PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6649432 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L5-S1 DEGENERATIVE DISC DISEASE WITH RADICULOPATHY AND UNDERWENT FOLLOWING PROCEDURE: L5-S1 LAMINECTOMY TO DECOMPRESS NERVE ROOT. L5-S1 INTERBODY FUSION WITH RHBMP-2/ACS. L5-S1 INTERBODY SPACER LOCAL BONE GRAFT L5-S1 SEGMENTAL PEDICULAR FIXATION WITH PEDICLE SCREWS EMG NERVE CONDUCTION STUDIES DURING SCREW INSERTION, 4 LEVELS TWO NERVES TESTED. AS PER OP-NOTES, ¿THE FACET JOINT AT L5-S1 WAS IDENTIFIED AN REMOVED. ONCE THE FACET JOINT WAS REMOVED, THE EPIDURAL SPACE WAS ENTERED AND A TRIANGULAR WORKING ZONE WAS IDENTIFIED. THE DISC SPACE WAS ENTERED USING A SERIES OF SEQUENTIAL DILATORS GOING FROM 6MM UP TO 12 MM. THE SPACE WAS DILATED NICELY OPEN AND THE INTERVERTEBRAL DISC SPACE REMOVED COMPLETELY. THE WOUND WAS THEN IRRIGATED. THE BONE CHIPS THAT WERE HARVESTED FROM THE FACET JOINT WERE TAKEN AND PLACED INTO THE ANTERIOR PORTION OF THE INTERSPACE. AN 11 MM SPACER WITH A PLEDGET OF RHBMP-2 WAS THEN PLACED INTO THE SPACE AND POUNDED INTO THE ANTERIOR HALF OF THE INTERVERTEBRAL DISC SPACE.¿ PATIENT TOLERATED THE PROCEDURE WITH NO COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 6649410 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH : L3-L4 AND L4-L5 SEVERE SPONDYLOSIS WITH REFRACTORY AXIAL AND RADICULAR BACK PAIN. LUMBAR 3-5 SPONDYLOSIS AND FORAMINAL STENOSIS WITH COMPRESSION OF THE NERVE ROOT AND UNDERWENT THE FOLLOWING PROCEDURES: L3-L4 AND L4-L5 DIRECT LATERAL EXTRA CAVITY DISCECTOMY AND INTERBODY FUSION USING PEEK, RHBMP-2/ACS AND PUTTY (RATTLESNAKE-EMINENT SPINE). BILATERAL L3,L4 AND L5 POSTERIOR SPINAL FUSION USING PEDICLE SCREWS AND RODS. LAMINECTOMY, LUMBAR, ANTERIOR/C SSEP. AS PER THE OPERATIVE NOTES: ¿ AN 8 X 22 MM PEEK INTERBODY SPACER WAS MALLETED INTO THE L3-L4 DISK SPACE. IN SIMILAR FASHION, THE L4-L5 DISK SPACE WAS IDENTIFIED AND ONCE AGAIN WHATEVER LITTLE REMNANT DISK MATERIAL WAS REMOVED IN THIS AREA. A 10 MM TLS CAGE WAS MALLETED INTO THIS L4-L5 REGION. THE BIGGER DLIF CAGE WOULD NOT FIT IN THE SPACE. ONCE BOTH IMPLANTS WERE IN PROPER POSITION AS CONFIRMED BY FLUOROSCOPY, HEMOSTASIS WAS OBTAINED.¿ IT WAS REPORTED THAT THE PATIENT HAVE BEEN DISABLED SINCE A SPINE IMPLANT DATE (B)(6) 2011.

  Patient problems: Disability

  MAUDE report 6628998 ↗
• InjuryMay 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTER BODY FUSION SURGERY USING RH-BMP2. POST OP PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 6565472 ↗
• InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: HERNIATED DISK, L5-S1 RIGHT; DEGENERATIVE DISK DISEASE L3-4, L4-5, L5-S1.THE PATIENT UNDERWENT FOLLOWING PROCEDURE: LUMBAR DISCECTOMY RIGHT L5-S1; POSTERIOR LUMBAR INTERBODY FUSION L3-4, L4-5, L5-S1; INSERTION OF BIOMECHANICAL DEVICE (PEEK CAGE L3-4, L4-5, L5-S1); POSTERIOR ARTHRODESIS L3 TO S1; PEDICLE SCREW INSTRUMENTATION, L3 TO S1; LOCAL BONE GRAFT HARVEST; BONE MARROW ASPIRATE; FLUOROSCOPY GREATER THAN ONE HOUR; MICROSCOPE. AS PER OP NOTES ¿ THIS WAS THEN PACKED WITH A COMBINATION OF BONE GRAFT AND BONE GRAFT MATERIAL. THEN A PEEK CAGE WAS INSERTED CONTAINING BONE GRAFT MATERIAL WITH DISTRACTION OF THE DISK SPACE. EPIDURAL SPACE WAS THEN IRRIGATED COPIOUSLY. THE EXITING AND TRAVERSING NERVE ROOTS WERE FOUND TO BE SUPPLE AND MOBILE AND HEMOSTASIS ACHIEVED¿. PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6228125 ↗
• InjuryDec 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2008, PATIENT UNDERWENT FOLLOWING PROCEDURE: ANTERIOR CERVICAL OSTEOTOMIES, C5 AND C7; MICROSCOPIC C6 AND C7 FORAMINO TOMIES; ANTERIOR FUSION WITH ALLOGRAFT AND PLATE FIXATION, C5-7. PRE-OP AND POST OP DIAGNOSIS: RIGHT C5 AND C6 RADICULOPATHY; NON-UNION OF PRIOR C5-6 AND C6-7 FUSIONS. PER-OPERATIVE NOTES: ".. FOLLOWING THE OSTEOTOMIES AND DECOMPRESSIONS, I PROCEEDED WITH ANTERIOR FUSIONS AT BOTH LEVEL. I USED CADAVER FIBULA SUPPLEMENTED WITH ALLOGRAFT CONSISTING OF BMP SOLUTION SATURATED INTO COLLAGEN SPONGES. IN ORDER TO SIZE THE GRAFTS I USED 6MM SPACER.. NO COMPLICATIONS WERE REPORTED.." PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6192212 ↗
• InjuryDec 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2014: AS PER THE IMPLANT LOG, INFUSE WAS USED IN A SURGERY. PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6172764 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT UNDERWENT A SPINAL FUSION SURGERY USING RHBMP-2/ACS. ON AN UNKNOWN DATE POST-OP, PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 6150496 ↗
• InjuryNov 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2011: AS PER THE IMPLANT LOG, THE PATIENT UNDERWENT REMOVAL OF HARDWARE, EXPLORATION OF L5-S1, L5 OSTEOTOMY, ALIF L5-S1 AND RHBMP-2/ACS WAS USED IN THE PROCEDURE. ON AN UNKNOWN DATE POST-OP, PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 6128399 ↗
• InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2008: PATIENT WAS IMPLANTED WITH RHBMP-2/ACS, CAGE AND RODS. PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6108722 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000058, P050053. One submission often covers many models, so check the product and lot details in each record.

• Z-1590-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1593-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1592-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1591-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1595-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1589-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1594-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic