Alexis® Orthopaedic Protector HR105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915138967), received between Feb 21, 2025 and Feb 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  NAME OF PROCEDURE BEING PERFORMED: TOTAL HIP ARTHROPLASTY - DIRECT ANTERIOR. DETAILED DESCRIPTION OF EVENT: AS AN UPDATE, WE ASKED FIELD LEADERSHIP TO REACH OUT TO THE ORTHO TEAM TO SEE IF THEY HAD ANY OUTSTANDING SCRUB FORMS THEY HAVE NOT TURNED INTO FIELD OPERATIONS FOR PROCESSING. AT THIS TIME, WE DISCOVERED AN ADDITIONAL SCRUB FORM FOR LOT# 1476912. I HAVE ATTACHED A COPY OF THE FORM FOR REFERENCE. IN ADDITION, THE ORTHO TEAM TAKES A PICTURE OF THE PRODUCT THEY ARE SCRUBBING IN TO ENSURE ACCURACY FOR THE POS. I HAVE ATTACHED THE IMAGE ASSOCIATED WITH THIS SCRUB FORM. PLEASE ME KNOW IF I CAN FURTHER ASSIST. ADDITIONAL INFORMATION OBTAINED FROM [NAME] (APPLIED MEDICAL FILED OPERATIONS MANAGER) VIA EMAIL ON 21FEB2025: YES, THIS DEVICE WAS USED IN A PROCEDURE. WE HAVE NOT HEARD OF ANY INJURY OR ILLNESS AT THIS TIME. I ALSO CONFIRMED THAT WHEN THE PRODUCT WAS PLACED, THE SURGEON IMMEDIATELY DETERMINED IT WAS THE WRONG SIZE AND IT WAS REMOVED. ADDITIONAL INFORMATION OBTAINED FROM [NAME] (APPLIED MEDICAL FILED OPERATIONS MANAGER) VIA EMAIL ON 25FEB2025: THE HR105 WAS REMOVED IMMEDIATELY SINCE THE INNER RING WAS TOO LARGE. TO MY KNOWLEDGE, NO OTHER SCRUB DEVICES WERE USED IN THE SAME P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463106 ↗
• MalfunctionFeb 21, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  NAME OF PROCEDURE BEING PERFORMED: COMPLEX THA REVISION. DETAILED DESCRIPTION OF EVENT: ON 1/29/25, WE RECEIVED A SCRUB PO FROM [NAME] FOR 1 EA HR105, LOT# 1476912. THIS WAS SCRUBBED IN FOR NO CHARGE AT [FACILITY] ON (B)(6) 2024 (ATTACHED). [NAME] NOTED THIS WAS FOR A COMPLEX THA REVISION BUT WAS NOT A SUCCESSFUL CASE, WHICH IS WHY SHE SCRUBBED IT IN FOR NO CHARGE. WHEN REVIEWING THE LOT NUMBER, WE DETERMINED THIS PRODUCT WAS NOT SENT TO [NAME]. WE ALSO DETERMINED THERE WAS NO RECORD OF THIS LOT NUMBER BEING SENT TO ANY FIELD TEAM MEMBER OR CUSTOMER. THERE WAS NO PRODUCTION HISTORY, WHICH PROMPTED US TO CHECK THE SHOP ORDER IN SAP. AFTER LOOKING UP THE SHOP ORDER, WE DETERMINED THE LOT WAS FROM AN ENGINEERING SHOP ORDER AND WAS NOT RELEASED INTO FINISHED GOODS. PER THE ATTACHED COPY, THE PURPOSE OF THE SHOP ORDER IS ¿TO BUILD UNITS FOR REAL-TIME AGING AND TESTING PER REAL-TIME AGING PROTOCOL DIR # [NUMBER].¿ WE HAVE REACHED OUT TO THE ENG TEAM TO DETERMINE WHAT HAPPENED TO THESE UNITS AND HOPEFULLY TRACE DOWN HOW [NAME] WAS ABLE TO OBTAIN ONE (EMAIL ATTACHED). WE ALSO CHECKED THE CLASSIFICATION T-CODE FOR THIS LOT, AND SAW IT IS NOT US APPROVED AND THERE IS NO STERILIZATION DATE. D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440052 ↗