NA 03.404.029SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982274038), received between Nov 9, 2022 and Jan 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Nov 19, 2020Class IITerminated

   RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

   Z-0584-2021 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Break; Entrapment of Device; Device-Device Incompatibility

  WHILE USING THE RIA 2 REAMER IRRIGATION SYSTEM, THE DISTAL LOCKING PINS FOR THE REAMER HEAD DISCONNECTED AND COULDN'T BE RETRIEVED. PER THE SURGEON, THEY WERE BACKING OUT THE REAMER WHEN THE HEAD DISENGAGED, HE ATTEMPTED TO REENGAGE THE REAMER HEAD AND WAS UNSUCCESSFUL, CAUSING THE LOCKING PINS TO COME OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 24193032 ↗
• MalfunctionDec 16, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT REAMER HEAD F/RIA 2 Ø16.5, REAMROD Ø2.5 L950 W/OLIVE, AND RIA 2 BONE HARVESTING KIT L520 WERE INVOLVED IN AN INTRA-OPERATIVE EVENT. DURING USE OF THE RIA 2 BONE HARVESTING SYSTEM IN A FEMORAL BONE GRAFT PROCEDURE, DIFFICULTY WAS ENCOUNTERED PASSING THE BALL-TIP DOWN THE FEMORAL CANAL, RESULTING IN A BEND AT THE DISTAL END. WHILE REAMING, AN UNUSUAL NOISE WAS HEARD, SUGGESTING THE RIA HEAD HAD DISENGAGED. SUBSEQUENT IMAGING REVEALED DEBRIS INSIDE THE CANAL. THE BALL-TIP AND REAMER HEAD WERE REMOVED, BUT DEBRIS REMAINED IN THE FEMORAL CANAL. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23817312 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT HARDWARE REMOVAL AFTER RIGHT HUMERUS NON-UNION. DURING THE PROCEDURE, BONE HARVEST CLOGGED INTO THE ASSEMBLY. THE RAI 2 SHAFT WAS STUCK INSIDE THE ASSEMBLY; THE PLASTIC WAS CUT AWAY FORM THE SHAFT. THIS REPORT IS FOR AN RAI 2 REAMER HEAD. THIS IS REPORT 5 OF 5 FOR (B)(4) CAPTURES THE INTRA-OPERATIVE RAI 2 ISSUES. RELATED COMPLAINT (B)(4) CAPTURES THE REQUIRED REVISION PROCEDURE DUE TO NON-UNION.

  Patient problems: Insufficient Information

  MAUDE report 19680380 ↗
• MalfunctionNov 9, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROVIDER WAS USING THE RIA 2 WITH BONE GRAFT IN ORDER TO OBTAIN A GRAFT. PROVIDER NOTED THAT THE RIA WAS NOT TAKING IN AS MUCH GRAFT AS USUAL. PROVIDER COMPLETED SURGERY WITHOUT HINDRANCE DESPITE THIS FACT. PATIENT STATUS UNKNOWN. NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 16.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759093 ↗