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INSTRUMENT I-K2710KB00Recalls & reported problems

Howmedica Osteonics Corp. · SPECIALTY TRIATHLON GAP BALANCER-SIZER · Class 2

All models of INSTRUMENT (131)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327258189), received between Oct 28, 2019 and Oct 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

Device problems

  • Component Missing1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2019Component Missing; Component Missing

    CENTRAL PROCESSING DEPARTMENT STAFF NOTIFIED ME THAT GAP BALANCING INSTRUMENT WAS MISSING A SMALL SCREW ON THE FRONT OF IT, CAUSING THE LOCK FEATURE TO NOT WORK ON IT. NOTICED IT WHILE PUTTING IT INTO A KIT. NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9246937 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page