RESTORE 219356Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705005963), received between May 6, 2013 and Feb 20, 2024 — classified as 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT SOMETHING WAS BLOCKED IN THE CANNULATION OF THE RESTORE FEMORAL AIMER 6 MM OFFSET DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737171 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN PORTUGAL THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE RESTORE FEMORAL AIMER 6 MM OFFSET DEVICE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447874 ↗
• MalfunctionJun 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT BEFORE AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL OF THE RESTORE FEMORAL AIMER 6 MM OFFSET DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093359 ↗
• MalfunctionMay 24, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RESTORE FEMORAL AIMER 6 MM OFFSET WAS SCOURING DRILL TIP PASSING PIN (THAT COMES IN ACL DISPOSABLE KIT) DURING DRILLING THAT METAL FRAGMENTS WERE CREATED. THE PROCEDURE WAS COMPLETED USING NORMAL TECHNIQUE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872085 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT DURING LOAN SET INSPECTION THAT THE FOOT OF THE GUIDE WIRE WAS BROKEN ON THE RESTORE FEMAIMER OFFSET. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952674 ↗
• MalfunctionMay 6, 2013Break; Break

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 3093481 ↗