VERSALOK ORTHOCORD 210808Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10886705001224), received between Mar 14, 2018 and May 16, 2026 — classified as 10 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC ANCHOR DEVICE COULD NOT BE SECURED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195143 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING PATELLAR DISLOCATION SURGERY, THE VERSALOK PRE PACKED W/OC ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569490 ↗
• MalfunctionOct 20, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC DEVICE ANCHOR PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335123 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GRYPHON P BR DS ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311216 ↗
• MalfunctionAug 26, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VERSALOK ANCHOR W/ORTHOCORD PEEK DEVICE WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893736 ↗
• MalfunctionAug 15, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC DEVICE ANCHOR WAS PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816371 ↗
• MalfunctionJul 25, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE VERSALOK PRE PACKED DEVICE ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 5 MIN DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607793 ↗
• MalfunctionMay 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE VERSALOK PRE PACKED W/OC DEVICE WAS MISSING AN OVERLINE RING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094833 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE VERSALOK PRE PACKED W/OC DEVICE ANCHOR WAS BROKEN WHILE IMPLANTING THE LATERAL ROW ANCHOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426345 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE VERSALOK PRE PACKED W/OC DEVICE ANCHOR WAS BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092653 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR OF THE VERSALOK WITH ORTHOCORD DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747089 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL PARTS WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712828 ↗
• MalfunctionOct 22, 2024Migration; Migration

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 4.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHOR BROKE OFF WHILE IN USE WITH THE VERSALOK PRE PACKED W/OC DEVICE. ALL BROKEN PARTS WERE REMOVED. THE ANCHOR WAS PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509464 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED BY A SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE VERSALOK ANCHOR WITH ORTHOCORD DEVICE WAS BROKEN OFF. 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 20437563 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON 2024 THE VERSALOK PRE PACKED W/OC DEVICE WAS BROKEN AND THE OUTER SHEATH WAS RUPTURED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911621 ↗
• MalfunctionJun 5, 2024Migration; Migration

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE VERSALOK PRE PACKED W/OC DEVICE PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472322 ↗
• MalfunctionJun 3, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6)2024 THE VERSALOK PRE PACKED W/OC DEVICE COULD NOT SECURE THE ANCHOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448710 ↗
• MalfunctionMay 22, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE VERSALOK PRE PACKED W/OC DEVICE COULD NOT SECURE THE ANCHOR. 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 19372320 ↗
• MalfunctionApr 3, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE VERSALOK PRE PACKED W/OC DEVICE COULD NOT SECURE THE ANCHOR. 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 19032827 ↗
• MalfunctionMar 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC SCREW DEVICE COULD NOT FIRE. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970580 ↗
• MalfunctionMar 20, 2024Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 THE VERSALOK PRE PACKED W/OC DEVICE ANCHOR WAS PULLED OUT TOGETHER WHEN THE SHAFT WAS 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 18939837 ↗
• MalfunctionFeb 8, 2024Migration; Migration

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC ANCHOR DEVICE PULLED OUT. 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 18672636 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE VERSALOK PRE PACKED W/OC DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. 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 18657730 ↗
• MalfunctionJan 29, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 3X VERSALOK PRE PACKED DEVICE COULD NOT SECURE THE ANCHOR. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594784 ↗
• MalfunctionJan 26, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 3X VERSALOK PRE PACKED DEVICE COULD NOT SECURE THE ANCHOR. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587244 ↗