Arthrex® AR-2950DRecalls & reported problems
Arthrex, Inc. · GRAFTPRO, GRAFT PREP BOARD · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867221505), received between Oct 25, 2023 and Aug 5, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn4
- Component Missing1
- Physical Resistance/Sticking1
- Residue After Decontamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2024Residue After Decontamination; Residue After Decontamination
ON 07/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2950D GRAFTPRO¿ GRAFT PREP BOARDS PRONGS GREW TO BE STICKY AND STARTED LEAVING A WHITE RESIDUE WHEN YOU MOVED THE PRONG ACROSS THE BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19904952 ↗MalfunctionMay 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 02/17/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-2950D GRAFT PREP BOARDS PAINT IS CHIPPING. THIS WAS DISCOVERED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19350543 ↗MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT TR-SC SURGERY THE SURGEON COMPLAINED ABOUT THE COLOR OF THE DEVICE, WHICH WAS BLACK IN THE PAST AND IS NOW SILVER. DUE TO THE REFLECTED LIGHT THE DEVICE GLARED COMPLETELY ON THE OPERATING TABLE AND ARE THEREFORE NOT USABLE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288748 ↗MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT TR-SC SURGERY THE SURGEON COMPLAINED ABOUT THE COLOR OF THE DEVICE, WHICH WAS BLACK IN THE PAST AND IS NOW SILVER. DUE TO THE REFLECTED LIGHT THE DEVICE GLARED COMPLETELY ON THE OPERATING TABLE AND ARE THEREFORE NOT USABLE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITHTHE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288681 ↗MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 02/28/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2950D GRAFT PREP BOARD PAINT IS PEELING OFF. THIS WAS DISCOVERED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288160 ↗MalfunctionNov 15, 2023Component Missing; Component Missing
ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06059959 THAT AN AR-2950D GRAFT PREP BOARD HAD MISSING SCREWS. IT WAS STATED THAT THE SCREW WAS FOUND AND HAD NO EFFECT ON THE PATIENT DURING SURGERY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18139122 ↗MalfunctionOct 25, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE SLIDER IS STUCK AND CAN'T BE MOVED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18002174 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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