RESTORE 219357Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705005970), received between Feb 28, 2018 and Feb 10, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT RESTORE FEMAIMER OFFSET 7MM *EA WAS BROKEN. IT WAS BROKEN DURING PROCESSING. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302298 ↗
• MalfunctionDec 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, IT WAS OBSERVED THAT THE RESTORE FEMAIMER OFFSET 7MM DEVICE APPEARED TO HAVE BENT AND COULD NOT EASILY BE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801037 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT METAL SHAVINGS CAME OUT WHILE PUTTING LONG PIECE IN THE RESTORE FEMORAL AIMER 7 MM DEVICE. ACCORDING TO THE REPORT, THE PROCEDURE WAS STOPPED TO CLEAN THE SHAVINGS AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF THREE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855512 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT METAL DEBRIS APPEARED AS THE EYELET NEEDLE WAS PASSED THROUGH AND ROTATED WITHIN THE RESTORE FEMAIMER OFFSET 7MM DEVICE. THE ARTICULAR SPACE WAS CLEANED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 13192723 ↗
• MalfunctionDec 14, 2020Inaccurate Information; Inaccurate Information

  IT WAS REPORTED BY THE AFFILIATE IN LEBANON THAT UPON OPENING THE RESTORE FEMAIMER OFFSET 7MM DEVICE IT WAS NOTICED THAT THE LOT NUMBER ON THE INSTRUMENT WAS DIFFERENT THAT THE ONE ON THE OUTER PACKAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN ANY PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003545 ↗
• MalfunctionDec 14, 2020Inaccurate Information; Inaccurate Information

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT UPON OPENING THE RESTORE FEMAIMER OFFSET 7MM DEVICE IT WAS NOTICED THAT THE LOT NUMBER ON THE INSTRUMENT WAS DIFFERENT THAT THE ONE ON THE OUTER PACKAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN ANY PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003415 ↗
• MalfunctionDec 14, 2020Inaccurate Information; Inaccurate Information

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT UPON OPENING THE RESTORE FEMAIMER OFFSET 7MM DEVICE IT WAS NOTICED THAT THE LOT NUMBER ON THE INSTRUMENT WAS DIFFERENT THAT THE ONE ON THE OUTER PACKAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN ANY PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003342 ↗
• MalfunctionAug 24, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE INNER WIRE OF THE RESTORE FEMORAL AIMER 7 MM OFFSET GOT STUCK INTO THE DEVICE. NO VISIBLE DAMAGE WAS FOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445792 ↗
• MalfunctionOct 29, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S RESTORE 7MM FEMORAL AIMER OFFSET TIP BROKE OFF IN THE PATIENT. THE SALES REP STATED THAT THE DEVICE BROKE WHILE THE SURGEON WAS FLEXING THE KNEE FOR DRILLING. THE TIP OF THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM, BUT A FIVE MINUTE DELAY TO REMOVE THE TIP OF THE DEVICE. THE SALES REP STATED THERE WAS NO NEED FOR FUTURE SURGICAL INTERVENTION. THE DEVICE IS BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8014952 ↗
• MalfunctionAug 5, 2018Break; Break

  THE SALES REP REPORTED THAT DURING AN ACL PROCEDURE THE DISTAL TIP OF THEIR FEMORAL AIMER 7 MM OFFSET BROKE OFF. THE SALES REP STATED THAT THEY HAD BELIEVED THAT THE DEVICE BROKE IN THE PATIENT; THEY SEARCHED THE JOINT SPACE FOR THE BROKEN TIP AND COULD NOT FIND THE BROKEN PIECE. THE SALES REP REPORTED THE SURGEON COMPLETED THE PROCEDURE WITH AN ARTHREX GUIDE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. SHE REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED X-RAYS WERE PERFORMED TO SEE IF THE BROKEN PIECE WAS IN THE PATIENT AND THE X-RAYS REVEALED THAT NOTHING LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE BROKEN PIECE WAS FOUND ON THE PATIENT TABLE UNDER PATIENT'S LEG OUTSIDE THE BODY. SHE STATED THAT THEY COMPARED THE PIECE TO THE DEVICE AND CONFIRMED THAT IS WAS THE BROKEN PIECE FROM THE DEVICE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER FOR THE DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750018 ↗
• MalfunctionFeb 28, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE TIP OF THEIR FEMORAL AIMER 7MM OFFSET WAS BROKE OFF PRIOR TO AN ACL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED. THE SALES REP WAS NOT PRESENT DURING THE CASE AND NOT ABLE TO PROVIDE A LOT NUMBER OR ANY MORE DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303234 ↗