PINNACLE GRIPTION TF 2217-01-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295097945), received between Jul 7, 2021 and Nov 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING ON DIVIDERS FOR INSTRUMENT SEATING WERE PEELING AND HOSPITALS WERE REJECTING THE DEVICES DUE TO CONTAMINATION LIABILITY. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618420 ↗
• MalfunctionDec 18, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  LOANER TRAYS ARE IN UNUSABLE CONDITION, GENERATING DEBRIS IN THE STERILIZER AND SETS. DID THE EVENT OCCUR DURING STERILE PROCESSING? YES, DID THE EVENT OCCUR DURING FIELD INSPECTION? YES, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, 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 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. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344636 ↗
• MalfunctionJul 7, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE INSTRUMENT BOXES WERE A BIT GRAY AFTER ALL THE CLEANING DONE BEFORE. NOW THEY WASHED THEM FOR THE FIRST TIME IN TRELLEBORG AND THE PAINT (BLACK) CAME OFF ON ALL OTHER INSTRUMENTS THAT WERE IN THE DISHWASHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129570 ↗