INSTRUMENT 6543-7-602Recalls & reported problems
Howmedica Osteonics Corp. · STOP PLATE TRIATHLON REVISION INSTRUMENTS · Class 1
All models of INSTRUMENT (131)
Data updated Oct 16, 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 07613327247374), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 16, 2026.
Most reported problems
Device problems
- Defective Device1
- Device Difficult to Setup or Prepare1
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionNov 15, 2019Device Difficult to Setup or Prepare; Defective Device; Device Difficult to Setup or Prepare; Defective Device
"THE STOP PLATE DOES NOT ASSEMBLE WITH THE REVISION TIBIAL RESECTION GUIDE (P/N 6543-6-701) AS THE CHAMFER ON THE RIGHT SIDE OF THE BLOCK MAKES CONTACT WITH THE END OF THE BLOCK WHILE THE BLOCK IS SUPPOSED TO SIT FLUSH. WHEN CHECKING THE STOP PLATE DIMENSIONS, WE FOUND IT DOES NOT MEET THE DRAWING SPECS." DISCOVERY MADE DURING PRODUCT DEVELOPMENT/ TESTING, DEVICES HAD BEEN ORDERED DIRECTLY FROM FINISHED GOODS. NO ASSOCIATED PROCEDURE. DEVICES HAVE BEEN DELIVERED TO THE COMPLAINT HANDLING DEPARTMENT. A PICTURE OF THE DEVICES IS ATTACHED. REPORTER HAS REQUESTED INVESTIGATION RESULTS.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9328752 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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