PINNACLE 2218-90-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295102311), received between Sep 5, 2018 and May 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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

• MalfunctionMay 6, 2026Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SZ 58 AB GRIPPER WAS CRACKED AND DID NOT HOLD THE CERAMIC LINER PROPERLY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? USED WITHOUT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096709 ↗
• MalfunctionSep 5, 2018Material Twisted/Bent

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE TAB ON AB INSERTER IS BENT AND WILL NO LONGER GRASP LINER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846505 ↗