Norian 07.704.005SRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982131614), received between Jun 13, 2018 and Apr 28, 2023 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (11 reports).

5 other recalls cover devices cleared under the same FDA submission (K073303, K102722); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN INTRA-OP AFTER THE NORIAN WAS MIXED, IT WAS PUT THROUGH THE ROLLING PRESS IN NORMAL FASHION. INSTEAD OF PUSHING THE NORIAN INTO THE SYRINGE, IT SQUEEZED OUT INTO THE PACKAGE MAKING IT UNUSABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TWO MINUTES OF SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16840272 ↗
• MalfunctionJan 11, 2023Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON REQUESTED TO USE 5CC OF NORIAN. AS THE CIRCULATING NURSE WAS PREPARING THE BONE VOID FILLER BY TWISTING THE SOLUTION SYRINGE INTO THE INJECTABLE PORT. THE PORT CRACKED AND THE SOLUTION LEAKED AS IT WAS INSERTED. NO PASTE WAS CREATED OR USED. THERE WAS NO SURGICAL DELAY AND NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138692 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DISLOCATED 2 FRAGMENT PROXIMAL HUMERUS FRACTURED, AND THERE WAS INCISIONAL SEROMA (INFECTION). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4)..

  Patient problems: Joint Dislocation; Seroma

  MAUDE report 15649897 ↗
• MalfunctionAug 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SODIUM HYALURONATE SOLUTION WAS SQUIRTING OUT OF THE ROTARY INJECTION PORT OF THE NORIAL DRILLABLE INJECT. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275655 ↗
• MalfunctionAug 2, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE MIXING 5CC OF NORIAN, CORRECT APPLICATION OF SOLUTION, REMOVED CAP, MIXED FOR 30 SECONDS. NORIAN WOULD NOT TRANSFER TO SYRINGE. THERE WERE A SURGICAL DELAY OF 10 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149249 ↗
• MalfunctionDec 7, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, THE NORIAN MIXING SOLUTION LEAKED OUT WHILE INJECTING. THE PROCEDURE WAS CONCLUDED USING A NEW 10CC NORIAN KIT. THERE WERE THREE (3) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 OR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956777 ↗
• MalfunctionAug 12, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE SYRINGE WAS BEING INJECTED INTO THE POUCH BUT THE POUCH WOULD NOT ACCEPT AND IT STARTED TO COME OUT INTO THE SIDE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316380 ↗
• MalfunctionJul 23, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE LIQUID FROM NORIAN DRILLABLE INJECT LEAKED OUT FROM CONNECTION TO POWDER PACKET WHEN INJECTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220721 ↗
• MalfunctionJun 28, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT, NORIAN WAS MIXED IN THE NORMAL FASHION. WHEN THE NORIAN POUCH WAS PLACED IN THE ROLLERS TO TRANSFER INTO THE SYRINGE, NOTHING CAME OUT. A NEW BOX OF NORIAN WAS OPENED AND MIXED IN THE SAME WAY WITH NO ISSUES. THEY CONCLUDED THAT THE ISSUE COULD NOT HAVE BEEN WITH MIXER UNIT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH (3) MINUTES OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075541 ↗
• MalfunctionJun 17, 2021Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN ISSUE WITH THE 5CC INJECT. WHILE SOLUTION WAS INJECTED INTO THE POUCH, SOME BUT NOT ALL SOLUTION STARTED LEAKING OUT OF THE SIDE OF THE LURE LOCK. AFTER RUNNING THE ROTARY MIXER FOR 70 SECONDS, THEY TRIED TO MOVED THE PUTTY INTO THE SYRINGE AND NOTHING LOADED INTO THE SYRINGE AT ALL. THIS DID NOT AFFECT PATIENT CARE AS THEY HAD ANOTHER 5CC WERE ABLE TO USE. AND WAS ABLE TO HOLD ONTO THE POUCH. IT IS UNKNOWN WHEN WAS THE ISSUE DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016369 ↗
• MalfunctionMay 18, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6), 2021 THE CIRCULATING NURSE WAS PREPARING THE NORIAN DRILLABLE INJECT. SHE WENT TO INJECT THE SODIUM SOLUTION, AND IT STARTED TO LEAK AT THE CONNECTION PORT. UPON FURTHER INSPECTION, THERE APPEARS TO BE A CRACK IN THE CONNECTION PORT OF THE MIXING POUCH. CIRCULATING NURSE OPENED UP ANOTHER NORIAN DRILLABLE INJECT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844698 ↗
• MalfunctionMay 11, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN PREPARING THE SALINE, THE PRODUCT WOULD NOT GO INTO THE BAG. WHEN THE SURGEON INJECTED, THERE WAS AN UNFAMILIAR CLICKING SOUND. THE BAG WAS UNABLE TO BE USED. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807972 ↗
• MalfunctionApr 27, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE NORIAN DRILLABLE INJECT 5CC STERILE LIQUID FOR NORIAN LEAKED OUT OF POWDER PACKAGE PRIOR TO MIXING WITH MIXER. OPENED ANOTHER NORIAN PACKAGE. NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734872 ↗
• MalfunctionApr 1, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE TWO EXTRA BOXES OF NORIAN DRILLABLE INJECT NEEDED TO BE OPENED BECAUSE THE NURSE FORGOT TO SQUEEGEE THE NORIAN INTO THE SYRINGE. TWO (2) NORIAN DRILLABLE INJECT CRACKED WHEN ATTACHING THE SYRINGE TO THE POUCH. IT WAS UNKNOWN WHEN THE ISSUE WHEN DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603493 ↗
• MalfunctionFeb 17, 2021Chemical Problem; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE NORIAN DRILLABLE INJECT FAILED TO INJECT AND DID NOT MIX PROPERLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339683 ↗
• MalfunctionJul 17, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROXIMAL TIBIA. DURING THE PROCEDURE, THE NORIAN DRILLABLE INJECT WAS STILL NOT "SETTING" AFTER 90 MINUTES OF IMPLANTATION. IT STILL HAD A WET CONSISTENCY TO IT AND WAS NOT PROVIDING THE STABILITY EXPECTED AFTER BEING IMPLANTED INTO A WARM PATIENT. THE SCREWS AND PLATES WERE IMPLANTED PER USUAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10291659 ↗
• MalfunctionMay 27, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE AFTER MIXING THE NORIAN DRILLABLE INJECT, THE SURGEON TRIED TRANSFERRING THE GRAFT INTO THE SYRINGE AND IT WOULD NOT FUNCTION. THE SYRINGE WAS NOT CONNECTED TO THE MIXING BAG AND THE GRAFT WAS LOST. SO THE SURGEON SQUEEZED THE MIX INTO THE STERILE PACKAGING. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. THE SURGEON HAD TO MIX A NEW BONE GRAFT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092859 ↗
• MalfunctionApr 1, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A NORIAN DRILLABLE INJECT 5CC WAS NOT ABLE TO MIX PROPERLY. IT DID NOT TURN INTO PASTE EVEN USING THE NORMAL TECHNIQUE AND PROCEDURE FOLLOWED, SO IT WOULD NOT EXCLUDE INTO THE SYRINGE, THE 5CC NORIAN AS DISCARDED AND THE SECOND BOX OF 3CC NORIAN WAS MIXED SUCCESSFULLY AND INSERT INTO THE PATIENT¿S FEMORAL HEAD BY THE SURGEON. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911394 ↗
• MalfunctionNov 28, 2018Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2018, THE NORIAN DRILLABLE INJECT WAS FOUND DISCONNECTED FROM THE PACKAGE. SPECIFICALLY, THE DELIVERY SYRINGE WAS DETACHED FROM THE PRODUCT POUCH. THE PRODUCT WAS WASTED AND NEVER MADE IT INTO THE STERILE FIELD WHILE MIXING AT THE BACK TABLE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111620 ↗
• MalfunctionNov 20, 2018Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIAL PLATEAU PROCEDURE ON (B)(6) 2018, WHEN THE NURSE ATTEMPTED TO THREAD THE SYRINGE ONTO THE PACKET AND THE PLASTIC PIECE CAME OFF THE SYRINGE. THE SYRINGE COULD NOT THREAD ONTO THE PACKET TO MAKE THE TRANSFER OF SOLUTION POSSIBLE. ANOTHER NORIAN DRILLABLE INJECT STERILE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF THREE TO FIVE MINUTES. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8088941 ↗
• MalfunctionAug 9, 2018Migration or Expulsion of Device; Chemical Problem; Improper Chemical Reaction; Migration or Expulsion of Device; Chemical Problem; Improper Chemical Reaction

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE NORIAN DRILLABLE INJECT WAS NOTED TO LEAK OUT. WHEN THE NURSE WAS PREPARING TO MIX THE NORIAN DRILLABLE INJECT, THE SOLUTION SYRINGE WOULD NOT INJECT INTO THE ROTARY POUCH AND LEAKED OUT COMPLETELY. ANOTHER NORIAN DRILLABLE INJECT WAS OPENED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN A MINUTE OR TWO DUE TO THE ISSUE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768360 ↗
• MalfunctionJul 16, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR PROXIMAL TIBIAL FRACTURE. DURING THE PROCEDURE, THE NORIAN DRILLABLE INJECT WAS NOT MIXED PROPERLY IN THE MIXING MACHINE AND WAS NOT DELIVERED INTO THE SYRINGE AS INTENDED. THE NORIAN DRILLABLE PACKAGING APPEARED TO BE THE ISSUE AND NOT THE MIXING MACHINE. ANOTHER BOX WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY REPORTED. THE PATIENT WAS STABLE THROUGHOUT THE SURGERY. CONCOMITANT DEVICE REPORTED: MIXING MACHINE (PART: MXR-UX-2000, LOT: UNKNOWN, QUANTITY: 1) . THIS REPORT IS FOR NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689624 ↗
• MalfunctionJul 11, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT DURING A HAND SURGERY ON (B)(6) 2018, THE NORIAN DRILLABLE INJECT 5CC SOLUTION WAS PROPERLY MIXED BUT FAILED TO TRANSFER INTO THE SYRINGE NEEDLE. THE NORIAN DRILLABLE INJECT WAS NOT USED. A SECOND NORIAN DRILLABLE INJECT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677739 ↗
• MalfunctionJun 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2018, THE PLASTIC END OF THE 5CC NORIAN DRILLABLE INJECT WAS DAMAGED WHILE ATTEMPTING TO MIX A 5CC OF NORIAN PRODUCT. WHEN THE NURSE WENT TO INJECT THE SOLUTION IN THE SYRINGE TO THE MIXER POUCH, THE PLASTIC LURE LOCK WAS ENGAGED TO TIGHT AND DAMAGED THE LURE LOCK ON THE SYRINGE. THIS MAY HAVE BEEN CAUSED BY SPINNING TOO FAST. INSTEAD, A 10CC NORIAN DRILLABLE PRODUCT WAS USED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS A SURGICAL DELAY OF LESS THAN FIVE (5) MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7610848 ↗
• InjuryJun 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE OF TIBIAL PLATEAU ON (B)(6) 2018. THE 5 CC NORIAN DRILLABLE INJECT WAS FINISHED MIXING USING THE ROTARY MIXER AND IT WOULD NOT TRANSFER INTO THE DELIVERY SYRINGE. THERE WAS A SURGICAL DELAY OF 2 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE 3 CC NORIAN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7595949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073303, K102722. One submission often covers many models, so check the product and lot details in each record.

• Z-0618-2018 · Aug 10, 2017 · Terminated
  Norian Drillable Inject
• Z-0617-2018 · Aug 10, 2017 · Terminated
  Norian Drillable Inject
• Z-1943-2016 · May 11, 2016 · Terminated
  Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony st
• Z-1944-2016 · May 11, 2016 · Terminated
  Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony s
• Z-1942-2016 · May 11, 2016 · Terminated
  Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony str