SPECTRUMRecalls & reported problems across all models
Conmed Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 12 models of SPECTRUM by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between May 24, 2017 and Mar 13, 2026 — classified as 3 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (32 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SPECTRUM problems
Device problems
- Material Fragmentation32
- Break4
- Detachment Of Device Component2
- Material Twisted/Bent2
- Detachment of Device or Device Component1
- Dull, Blunt1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient10
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Laceration(s)1
SPECTRUM models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPECTRUM C6370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- SPECTRUM C6360ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- SPECTRUM C6380ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- SPECTRUM C6362ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Spectrum C6361ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- SPECTRUM C6381ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- SPECTRUM C6382ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SPECTRUM C6384ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- SPECTRUM C6385ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- SPECTRUM C6386ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Spectrum C6387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- SPECTRUM C6369ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent SPECTRUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6384 SPECTRUM II SUTURE HOOK, DISPOSABLE, STRAIGHT DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED ¿WE HAD A DISPOSABLE SUTURE HOOK BREAK WHEN TRYING TO PIERCE THROUGH TISSUE. WE WERE ABLE TO PULL BOTH PIECES OUT AS THE WIRE WAS STILL RUNNING THROUGH IT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590071 ↗MalfunctionDec 19, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE THAT THE C6380 SPECTRUM II SUTURE HOOK, DISPOSABLE, 45° RIGHT DEVICE WAS BEING USED ON (B)(6) 2025 DURING AN INSTABILITY REPAIR PROCEDURE WHEN IT WAS REPORTED ¿TIP BROKE OFF ON FIRST PASS ATTEMPT THROUGH LABRUM WITH MILD PRESSURE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. PROCEDURE WENT WELL WITH A SECOND DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854912 ↗MalfunctionDec 17, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, C6370 SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED ON (B)(6) 2025 AND "DURING AN ARTHROSCOPIC LABRAUM REPAIR PROCEDURE, THE DISTAL TIP OF THE SUTURE HOOK INSTRUMENT FRACTURED WHILE PASSING THROUGH THE TISSUE, WITHOUT CONTACT WITH BONE STRUCTURES.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "ACCORDING TO THE SURGEON¿S REPORT, ONLY A COMPONENT OF THE DEVICE ¿THE DISTAL TIP OF THE SUTURE HOOK ¿ DETACHED DURING PASSAGE THROUGH THE LABRAL TISSUE, WITHOUT CONTACTING ANY BONE STRUCTURES. THE FRAGMENT FELL INTO THE SURGICAL SITE BUT WAS IMMEDIATELY VISUALIZED AND RETRIEVED WITHOUT COMPLICATION, AFTER WHICH THE INSTRUMENT WAS REPLACED TO CONTINUE THE PROCEDURE." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED. WITH REPLACEMENT OF THE DISTAL PASSER TIP (INTEGRATED NEEDLE), WITHOUT FURTHER INCIDENT¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828590 ↗MalfunctionSep 25, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, C6369, SPECTRUM II SUTURE HOOK, SMALL CRESCENT WAS BEING USED ON (B)(6) 2025 DURING A KNEE ARTHROSCOPY FOR MENISCUS SUTURE AND "USE OF THE SPECTRUM HOOK (CONMED). 4TH USE (PREVIOUSLY ON (B)(6) 2025; (B)(6) 2025; (B)(6) 2025). THE RIGHT HOOK BROKE INSIDE THE JOINT DURING THE PROCEDURE WITHOUT THE SURGEON FORCING IT. THE PIECE OF METAL WAS RECOVERED AND DID NOT REMAIN IN THE PATIENT'S KNEE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23141970 ↗MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6380 SPECTRUM II SUTURE HOOK, DISPOSABLE, 45° RIGHT DEVICE WAS BEING USED DURING A LABRAL PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿SURGEON WAS USING SPECTRUM WITH THE RIGHT HOOK, HOOK BROKE OFF. SURGEON DID NOT SEEM TO BE FORCING IT THROUGH THE TISSUE. SURGEON REMOVED THE PIECE AND A BLITZ WAS OPENED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066103 ↗MalfunctionAug 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, C6361, SPECTRUM II SUTURE HOOK, 45° LEFT, WAS BEING USED DURING A MENISCAL REPAIR PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿DURING THE OPERATION, THE SURGEON TRIED TO USE THE HOOK FOR PASSING THE SUTURE. BUT WHEN HE USED THE HOOK TO PIERCE THROUGH THE MENISCUS AND THE TIP OF HOOK WAS BROKEN.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING OF THE REPORTER FOUND THAT ¿THE BROKEN FRAGMENT HAD FALLEN INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED FROM SURGICAL SITE. SURGEON USED STRAIGHT ARTERY FORCEPS TO REMOVE THE FRAGMENT." AND THE PATIENT WAS "DISCHARGED FROM HOSPITAL.¿ THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22685291 ↗MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6382 SPECTRUM II SUTURE HOOK, DISPOSABLE, 60° RIGHT DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2025 WHEN IT WAS REPORTED ¿THE HOOK PART BROKE LOOSE FROM THE SHAFT OF THE PRODUCT, THIS HAPPENED INSIDE THE PATIENT'S SHOULDER JOINT BUT COULD BE MANUALLY RECOVERED.¿ THERE WAS NO REPORT PF INJURY, MEDICAL OR SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22564093 ↗MalfunctionJun 16, 2025Material Fragmentation; Material Fragmentation
A CUSTOMER REPORTED THAT THE C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND "STERILIZED SPECTRUM HOOK 2 TIMES AND NOT YET USED; THE HOOK TIP HAS BROKEN IN THE PATIENT¿S SHOULDER; WE RECOVERED THE TIP; NEW EQUIPMENT THAT SHOULD NOT BE BROKEN AT THE FIRST USE¿. THE PROCEDURE WAS COMPLETED, AND THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210305 ↗MalfunctionFeb 5, 2025Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6386 SPECTRUM II SUTURE HOOK, DISPOSABLE, MEDIUM CRESCENT WAS BEING USED ON (B)(6) 2025 DURING A SHOULDER ARTHROSCOPY AND THE ¿PIECE OF DISPOSABLE MEDIUM CRESCENT HOOK BROKE OFF INTO THE PATIENT¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE "ENTIRE MEDIUM CRESCENT 'HOOK' PORTION BROKE OFF OF THE SHAFT INTO THE PATIENTS SHOULDER." THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A ¿REUSABLE CONMED SPECTRUM HOOK¿. THERE WAS A 30 MINUTE DELAY. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT AND THE PATIENT WAS REPORTED AS ¿GOOD CONDITION¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314016 ↗MalfunctionDec 19, 2024Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6361 SPECTRUM II SUTURE HOOK, 45° LEFT WAS BEING USED ON 05DEC24 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿BROKE DURING A CASE THIS WEEK. THE HOOK BROKE OFF INSIDE OF THE PATIENT. IT LOOKS LIKE THE HOOK WAS STERILIZED 4 TIMES. NO INJURY. THEY WERE ABLE TO REMOVE FROM PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20977528 ↗MalfunctionDec 9, 2024Material Fragmentation; Material Fragmentation
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE C6380, SPECTRUM II SUTURE HOOK, DISPOSABLE, 45° RIGHT DEVICE WAS USED IN A LABRAL REPAIR PROCEDURE ON (B)(6) 2024, AND ¿LABRAL REPAIR USING SPECTRUM2 WITH DISPO HOOKS. THE HOOK BROKE OFF WHEN ATTEMPTING TO PASS SUTURE AROUND BICEP TENDON. NO KNOWN PATIENT IMPACT AT THIS TIME¿. PER FURTHER ASSESSMENT, ALL FRAGMENTS WERE RETRIEVED WITH "LIKELY A GRASPER". THE PROCEDURE WAS COMPLETED AS NORMAL WITH A "REPLACEMENT SPECTRUM HOOK", AND A DELAY OF UNKNOWN DURATION. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, WHOSE STATUS IS DESCRIBED AS "FINE". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880671 ↗MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT, WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿TIP BROKE DURING THE SURGERY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FOUND THAT THE TIP HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20438243 ↗MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, C6360, SPECTRUM II SUTURE HOOK, 45° RIGHT, WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿TIP BROKE DURING THE SURGERY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FOUND THAT THE TIP HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20438242 ↗MalfunctionOct 8, 2024Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE C6370, SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED ON (B)(6) 2024 DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED ¿MEDIUM SUTURE HOOK BROKE YESTERDAY IN A PATIENT'S SHOULDER.¿. FURTHER ASSESSMENT FOUND THAT ¿A GRAPSER WAS USED TO RETRIEVE THE NEEDLE.¿. THE PROCEDURE WAS COMPLETED AND ¿THE DEVICE BREAKING DID NOT CAUSE INJURY TO PATIENT. CURRENT STATUS IS UNKNOWN.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396232 ↗MalfunctionSep 30, 2024Material Fragmentation; Material Fragmentation
A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE C6360, SPECTRUM II SUTURE HOOK, 45° RIGHT DEVICE WAS BEING USED DURING A SHOULDER ROTATOR CUFF PROCEDURE ON (B)(6) 2024, AND "DURING THE OPERATION, WHILE THE SURGEON WAS USING THE INSTRUMENT, THE HOOK GOT BROKEN FROM THE HOOK SIDE BROKEN PIECE HAS BEEN RETRIEVED FROM PATIENT WITH NO HARM.". THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10-15 MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. THE C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT WILL BE LISTED AS A CONCOMITANT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333431 ↗
Other Conmed Corporation products
All Conmed Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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