SPECIALIST 96-6330Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 TRAY TRIAL ALIGNMENT HANDLE · Class 1
All models of SPECIALIST (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295247913), received between Feb 7, 2018 and Feb 11, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break3
- Device-Device Incompatibility2
- Device Slipped1
- Naturally Worn1
- Structural Problem1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2022Structural Problem; Naturally Worn; Structural Problem; Naturally Worn
IT WAS REPORTED THAT THE SPRING NO LONGER WORKING. FOUND OUT PRIOR TO CASE WHILE PREPPING, NEW KIT BROUGHT IN, NO AFFECT ON CASE OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13514204 ↗MalfunctionAug 4, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE MBT TRAY TRIAL ALIGNMENT HANDLE WAS DAMAGED. IT WOULD NO LONGER ATTACH TO THE TRAY/BASEPLATE TRIALS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274377 ↗MalfunctionMay 28, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIP OF THE TIBIA HANDLE WAS NOT ENGAGING THE TIBIA TRAY PROPERLY. IT WAS VERY LOOSE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10098233 ↗MalfunctionSep 19, 2018Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BEING USED AND WERE BROKE DURING THE CASE. THIS IS ALL THE INFORMATION I HAVE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7888942 ↗MalfunctionAug 15, 2018Break; Break
ALIGNMENT HANDLE WAS BROKEN AND WAS DISCARDED AT SOURCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784978 ↗MalfunctionFeb 7, 2018Break; Break
IT WAS REPORTED THAT THE LOCKING TAB WAS DAMAGED DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7247271 ↗
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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