RESTORERecalls & reported problems across all models
Medos International Sàrl · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 164
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 33 models of RESTORE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 164 adverse event reports in the FDA's MAUDE database, received between May 6, 2013 and May 11, 2026 — classified as 2 injuries, 162 malfunctions.
The most frequently reported specific device problem is “Degraded” (39 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 RESTORE problems
Device problems
- Degraded39
- Dull, Blunt32
- Break27
- Material Deformation18
- Device Contaminated During Manufacture or Shipping16
- Inaccurate Information13
- Illegible Information9
- Mechanical Jam8
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- No Consequences Or Impact To Patient47
- Not Applicable6
- Foreign Body In Patient3
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
RESTORE models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RESTORE 219340REAMER16 reports
- RESTORE 219321ACCESSORIES,ARTHROSCOPIC14 reports
- RESTORE 219301Guide, surgical, instrument11 reports
- RESTORE 219357ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- RESTORE 219349REAMER10 reports
- RESTORE 219348REAMER9 reports
- RESTORE 219335REAMER7 reports
- RESTORE 219338REAMER7 reports
- RESTORE 219328ACCESSORIES,ARTHROSCOPIC6 reports
- RESTORE 219356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- RESTORE 219555REAMER6 reports
- RESTORE 219313ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- RESTORE 219337REAMER5 reports
- RESTORE 219347REAMER5 reports
- RESTORE 219556REAMER5 reports
- RESTORE 219346REAMER4 reports
- RESTORE 219303ACCESSORIES,ARTHROSCOPIC3 reports
- RESTORE 219336REAMER3 reports
- RESTORE 219341REAMER3 reports
- RESTORE 219342REAMER3 reports
- RESTORE 219358ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- RESTORE 219554REAMER3 reports
- RESTORE 219558REAMER3 reports
- RESTORE 219306ACCESSORIES,ARTHROSCOPIC2 reports
- RESTORE 219308ACCESSORIES,ARTHROSCOPIC2 reports
- RESTORE 219339REAMER2 reports
- RESTORE 219550REAMER2 reports
- RESTORE 219553REAMER2 reports
- RESTORE 219557REAMER2 reports
- RESTORE 219343REAMER1 report
- RESTORE 219351ACCESSORIES,ARTHROSCOPIC1 report
- RESTORE 219551REAMER1 report
- RESTORE 232015ACCESSORIES,ARTHROSCOPIC1 report
Recent RESTORE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Material Deformation
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SHAFT OF THE RESTORE DEVICE WAS BENT, CAUSING IT TO WOBBLE WHEN ROTATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25138120 ↗MalfunctionMar 6, 2026Material Deformation
IT WAS REPORTED THAT THE ACL DRILLPN W/EYE .094X14 DEVICE AND RIGIDLOOP REAMER 4.5MM DEVICE WERE DEFECTIVE; BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534749 ↗MalfunctionFeb 17, 2026Mechanical Jam
IT WAS REPORTED THAT THE RESTORE ACORNREAM 7MM THIN DEVICE WAS STUCK ON THE CHUCK DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366893 ↗MalfunctionFeb 10, 2026Break
IT WAS REPORTED BY SALES REP VIA EMAIL THAT RESTORE FEMAIMER OFFSET 7MM *EA WAS BROKEN. IT WAS BROKEN DURING PROCESSING. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302298 ↗MalfunctionFeb 6, 2026Degraded
IT WAS REPORTED THAT DURING AN UNKNOWN KNEE PROCEDURE, THE RESTORE FULLFLUTE REAM 10MM DEVICE WAS DULL AND WE HAD TO USE THE 10 FEMUR BIT TO PERFORM THE TIBIAL TUNNEL THUS ACHIEVING TO FINISH THE SURGERY SUCCESSFULLY WITHOUT DISCOMFORT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283051 ↗MalfunctionDec 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, IT WAS OBSERVED THAT THE RESTORE FEMAIMER OFFSET 7MM DEVICE APPEARED TO HAVE BENT AND COULD NOT EASILY BE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23801037 ↗MalfunctionSep 19, 2025Degraded; Overheating of Device; Degraded; Overheating of Device
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 9MM EA DEVICE SCREW DRIVE HANDLE RACHE DID NOT WORK. THE NINE-TIBIA BIT HAD NO EDGE WHICH GENERATED OVERHEATING OF THE BONE AND HANDPIECE. THE DEVICE WAS USED WITH THE ASMBLY, RATCHET HANDLE, QUICK DISCONNECT DEVICE. THERE WERE NO REPORTS OF DELAYS IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095267 ↗MalfunctionFeb 28, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (RIGHT KNEE) SURGICAL PROCEDURE WHILE USING THE TWISTR ACL DISPOSABLES KIT DEVICE A DRILL TIP PASSING PIN BROKE WHILE LOADED ON POWER AND ADVANCING FROM THE TIBIA INTO THE FEMUR (TRANSTIBIAL APPROACH). THE TIP OF THE DRILL PIN BROKE OFF AND IS CONTAINED WITHIN THE CORTICAL BONE OF THE FEMUR. THE SURGEON DECIDED TO LEAVE THE METAL FRAGMENT SINCE IT WAS CONTAINED IN THE BONE. THE PASSING PIN WAS BENT ONCE REMOVED FROM THE KNEE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT A TIME DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21496597 ↗MalfunctionFeb 24, 2025Degraded; Degraded
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM DEVICE WAS EXTREMELY DULL. THERE WAS A SLIGHT UNSPECIFIED DELAY IN THE PROCEDURE REPORTED AS IT TOOK LONGER TO USE THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444768 ↗MalfunctionFeb 10, 2025Degraded; Dull, Blunt; Degraded; Dull, Blunt
IT WAS REPORTED THAT WHILE PERFORMING AN ANTERIOR CRUCIATE LIGAMENT TECHNIQUE, DURING THE BROCADE OF THE TIBIA, A DRILL BIT DEVICE OF TIBIA WAS USED WITH THE RESTORE FULLFLUTE REAM DEVICE WHICH WAS INEFFICIENT AND THE ASSISTANT SPECIALIST HAD TO EXERT MORE FORCE TO PERFORM THE TUNNEL AND IN TURN. A LOT OF DELAY OCCURRED DURING THIS STEP, THE STATE OF THE MOTOR AND BATTERY WERE VERIFIED TO RULE OUT FAILURES OF THE POWER EQUIPMENT. SATISFACTORY TO THE ASSESSMENT IN TERMS OF FORCE AND SPEED, THIS BEING RULED OUT AS CAUSAL. THE PROCESS TAKES LONGER THAN USUAL TO CROSS THE METAPHYSIS AND EFFECTIVELY PERFORATE THE ARTICULAR CORTEX OF THE TUNNEL, THE TIP OF THE BUTTONHOLE PIN WAS PROTECTED WITH A CURETTE, HOWEVER, THE FORCE ADMINISTERED TO BE ABLE TO PIERCE THE ARTICULAR CORTEX MUST BE SO MUCH THAT AT THE EXIT OF THE JOINT. IT WAS IMPOSSIBLE TO CONTROL THAT THE DRILL BIT WAS NOT AT THE END OF THE JOINT. THIS IS REPORT 2 OF 2 OF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21348814 ↗MalfunctionNov 29, 2024Degraded; Illegible Information; Degraded; Illegible Information
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RESTORE ACORNREAM 10MM THIN DEVICE BLADE WAS DULL AND MEASUREMENTS WERE HARD TO READ AS THE DEVICE WAS USED ALOT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809355 ↗MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information
THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 10MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20220931 ↗MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information
THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE ACORNREAM 10MM THIN DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20220930 ↗MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information
THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 6MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20220929 ↗MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information
THIS IS REPORT 8 OF 10 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 8MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20220914 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
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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