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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 4 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

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

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