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Arthrex® AR-14244Recalls & reported problems

Arthrex, Inc. · FRAC PLT SCRW LOC. CANC. 4.0X44MM TI · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867017412), received between May 3, 2024 and Dec 26, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 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: 2 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated2
  • Loosening of Implant Not Related to Bone-Ingrowth2
  • Physical Resistance/Sticking1

Patient problems

  • Failure of Implant2
  • Nonunion/Delayed-union Bone Fracture2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 26, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

    ADDITIONAL INFORMATION WAS RECEIVED ON 12-MAR-2026:ON (b)(6) 2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE. ADDITIONAL INFORMATION WAS RECEIVED ON 20-APR-2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6) 2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON (b)(6) 2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6) 2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON (b)(6) 2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN (b)(6).ADDITIONAL INFORMAT

    Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23897424 ↗
  • InjuryDec 26, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

    ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6)2026:ON (b)(6)2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE. ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6)2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6)2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON(b)(6)2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6)2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON (b)(6)2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN MAY.ADDITIONAL INFORMATION WAS REC

    Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23897328 ↗
  • MalfunctionMay 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING AN ORIF PROXIMAL HUMERUS SURGERY THE SCREW AR-14244 GOT STUCK IN THE HUMERAL PLATE AR- 14003 (LOT NUMBER: 15103696). THE SURGEON HAD TO REMOVE THE PLATE TOGETHER WITH THE SCREW AND A NEW PLATE HAD TO BE USED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19238024 ↗

Other PLATE, FIXATION, BONE devices

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Sources and updates

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