GLOBAL STEPTECH APG 2230-00-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295102793), received between Nov 9, 2017 and Nov 21, 2023 — classified as 4 malfunctions.

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

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.

• MalfunctionNov 21, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT GUIDES HAVE GOUGES OUT OF THEM AND ARE NOT SMOOTH PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181790 ↗
• MalfunctionDec 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON ASKED THAT WE REPLACE SOME OF THE SIZING/PIN GUIDES FOR THE ANCHOR PEG PLUS INSTRUMENTS. THE DISKS ARE "SLIPPING" ON THE HANDLE. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951350 ↗
• MalfunctionApr 4, 2019Break; Component Missing; Appropriate Device Problem Term/Code Not Available; Break; Component Missing; Appropriate Device Problem Term/Code Not Available

  THE ST APG SIZER PIN GUIDE 44+3 WAS REPORTED TO BE CHIPPED WITH MATERIAL MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483854 ↗
• MalfunctionNov 9, 2017Break; Break

  DURING THE INSPECTION OF A NEW SIZER PIN GUIDE, THE ORTHOKIT TECHNICIAN NOTICES THAT THE INSTRUMENT IS NOT SPLIT AS IT SHOULD BE AND THE LOT NUMBER THAT IS INDICATED IN THE LABEL DOES NOT CORRESPOND TO THE LOT NUMBER ETCHED ON THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7016713 ↗