T-PAL 03.812.507Recalls & reported problems
Synthes GmbH · T-PAL TRIAL SPACER 12MM X 32MM 7MM HEIGHT · Class 1
All models of T-PAL (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034727936), received between Oct 22, 2018 and May 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Compatibility Problem1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Compatibility Problem; Compatibility Problem
IT WAS REPORTED THE KNOB OF THE INSTRUMENT GOT CAUGHT IN THE TRIAL CAGE AND CANNOT BE REMOVED. THERE WERE NO CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION/REVISION PROCEDURE REQUIRED.
Patient problems: Insufficient Information
MAUDE report 22011270 ↗MalfunctionOct 22, 2018Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, TWO APPLICATOR KNOBS WERE NOTED TO BE STIFF (ONE SEIZED AND NOT USABLE) AND LOOKED RUSTED AROUND THE INTEGRATED BUTTON ON ONE APPLICATOR KNOB. THE TEAM WAS NOT HAPPY TO CONTINUE USING THE SET MOVING FORWARD UNLESS BOTH COMPLETE HANDLES INCLUDING TWO APPLICATOR OUT SHAFTS WERE REPLACED IN CASE, THESE WERE ALSO STIFF CAUSING THE PROBLEM. THE T-PAL LARGE TRIAL IMPLANT WAS BROKEN, AND THE BALL TIP WAS WITHIN THE APPLICATOR KNOB. THE T-PAL ITEMS WERE USED ALTHOUGH IT WAS TOUGH TO DO SO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE. PATIENT OUTCOME WAS REPORTED AS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 12MM X 32MM 7MM HEIGHT. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7992441 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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