SPECIALISTRecalls & reported problems across all models
Depuy (Ireland) · 80 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,848
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 1
We found 80 models of SPECIALIST by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 1,848 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2016 and Sep 29, 2026 — classified as 9 injuries, 1,839 malfunctions.
The most frequently reported specific device problem is “Break” (1,114 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SPECIALIST recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 8, 2015Class IITerminated
DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
Z-0111-2016 · Root cause: Device Design · Recall details · FDA record ↗
Most reported SPECIALIST problems
Device problems
- Break1,114
- Device-Device Incompatibility223
- Naturally Worn177
- Material Deformation138
- Crack120
- Material Twisted/Bent93
- Material Integrity Problem47
- Mechanical Jam47
Patient problems
- No Clinical Signs, Symptoms or Conditions858
- No Consequences Or Impact To Patient788
- No Information102
- Insufficient Information79
- No Code Available33
- Not Applicable33
- Foreign Body In Patient3
- No Known Impact Or Consequence To Patient3
SPECIALIST models
80 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPECIALIST 2581-11-000IMPACTOR704 reports
- SPECIALIST 96-6520ORTHOPEDIC MANUAL SURGICAL INSTRUMENT190 reports
- SPECIALIST 96-6180IMPACTOR173 reports
- SPECIALIST 86-5035CLAMP101 reports
- SPECIALIST 96-6120TEMPLATE1 recall32 reports
- SPECIALIST 96-5383IMPACTOR64 reports
- SPECIALIST 96-6385IMPACTOR60 reports
- SPECIALIST 96-6295SCREWDRIVER48 reports
- SPECIALIST 96-6115INSTRUMENT, CUTTING, ORTHOPEDIC34 reports
- SPECIALIST 96-6505DRIVER, PROSTHESIS30 reports
- SPECIALIST 99-1016TEMPLATE28 reports
- SPECIALIST 96-6110TEMPLATE24 reports
- SPECIALIST 96-6144INSTRUMENT, CUTTING, ORTHOPEDIC24 reports
- SPECIALIST 96-6311TEMPLATE23 reports
- SPECIALIST 96-6147ORTHOPEDIC MANUAL SURGICAL INSTRUMENT22 reports
- SPECIALIST 96-6242INSTRUMENT, CUTTING, ORTHOPEDIC19 reports
- SPECIALIST 96-6310TEMPLATE19 reports
- SPECIALIST 96-6510HAMMER, SURGICAL19 reports
- SPECIALIST 96-6112TEMPLATE17 reports
- SPECIALIST 96-6145INSTRUMENT, CUTTING, ORTHOPEDIC16 reports
- SPECIALIST 96-6515EXTRACTOR15 reports
- SPECIALIST 96-6648ORTHOPEDIC MANUAL SURGICAL INSTRUMENT15 reports
- SPECIALIST 96-6384ORTHOPEDIC MANUAL SURGICAL INSTRUMENT12 reports
- SPECIALIST 96-6530TEMPLATE12 reports
- SPECIALIST 96-6181IMPACTOR11 reports
- SPECIALIST 96-6143INSTRUMENT, CUTTING, ORTHOPEDIC10 reports
- SPECIALIST 86-8800INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT9 reports
- SPECIALIST 96-6321INSTRUMENT, CUTTING, ORTHOPEDIC8 reports
- SPECIALIST 96-6312TEMPLATE7 reports
- SPECIALIST 96-6200INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- SPECIALIST 96-6315TEMPLATE6 reports
- SPECIALIST 96-6330TEMPLATE6 reports
- SPECIALIST 96-6325TEMPLATE5 reports
- SPECIALIST 96-6327INSTRUMENT, CUTTING, ORTHOPEDIC5 reports
- SPECIALIST 96-6381INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT5 reports
- SPECIALIST 96-6131TEMPLATE4 reports
- SPECIALIST 96-6152INSTRUMENT, CUTTING, ORTHOPEDIC4 reports
- SPECIALIST 96-6360TEMPLATE4 reports
- SPECIALIST 96-6361TEMPLATE4 reports
- SPECIALIST 9505-01-024TEMPLATE3 reports
- SPECIALIST 96-6318INSTRUMENT, CUTTING, ORTHOPEDIC3 reports
- SPECIALIST 96-6371PUNCH, SURGICAL3 reports
- SPECIALIST 96-6142INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- SPECIALIST 96-6245INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- SPECIALIST 96-6335TEMPLATE2 reports
- SPECIALIST 96-6376ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SPECIALIST 96-6402TEMPLATE2 reports
- SPECIALIST 96-6552TRAY, SURGICAL, INSTRUMENT2 reports
- SPECIALIST 86-0590ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- SPECIALIST 96-6121TEMPLATE1 report
- SPECIALIST 96-6136TEMPLATE1 report
- SPECIALIST 96-6166TEMPLATE1 report
- SPECIALIST 96-6243INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- SPECIALIST 96-6244INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- SPECIALIST 96-6249INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- SPECIALIST 96-6301DRIVER, PROSTHESIS1 report
- SPECIALIST 96-6305TEMPLATE1 report
- SPECIALIST 96-6320INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- SPECIALIST 96-6322INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- SPECIALIST 96-6341TEMPLATE1 report
- SPECIALIST 96-6342TEMPLATE1 report
- SPECIALIST 96-6343TEMPLATE1 report
- SPECIALIST 96-6366PUNCH, SURGICAL1 report
- SPECIALIST 96-6372PUNCH, SURGICAL1 report
- SPECIALIST 96-6395TEMPLATE1 report
- SPECIALIST 96-6400TEMPLATE1 report
- SPECIALIST 96-6401TEMPLATE1 report
- SPECIALIST 96-6403TEMPLATE1 report
- SPECIALIST 96-6404TEMPLATE1 report
- SPECIALIST 96-6405TEMPLATE1 report
- SPECIALIST 96-6430EXTRACTOR1 report
- SPECIALIST 96-6553TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6572TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6574TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6583TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6584TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6586TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6587TRAY, SURGICAL, INSTRUMENT1 report
- SPECIALIST 96-6588ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- SPECIALIST 96-6602TEMPLATE1 report
Recent SPECIALIST adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
It was reported that rubber impactor came off of impaction metal tip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931362 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828408 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794165 ↗MalfunctionAug 6, 2026Corroded; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50162881 ↗MalfunctionJul 2, 2026Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE IMPACTORS WERE SCRATCHED TO A POINT WHERE THEY CANNOT BE REPROCESSED DUE TO POSSIBLE COMPROMISED STERILITY, PER FACILITIES. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690364 ↗MalfunctionJun 24, 2026Material Deformation
IT WAS REPORTED THAT FEMORAL IMPACTOR SCREWS ARE STRIPPED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608644 ↗MalfunctionJun 24, 2026Material Deformation
IT WAS REPORTED THAT SCREWS ON FEMORAL IMPACTOR ARE STRIPPED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608389 ↗MalfunctionJun 17, 2026Break
IT WAS REPORTED THAT THE TIBIAL CEMENTLESS IMPACTOR BROKE AT THE CONNECTION PART WHEN BEING MALLETED IN CASE. IT WAS UNKNOWN IF THERE WAS A DELAY DUE TO THE REPORTED EVENT. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538099 ↗MalfunctionMay 14, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE THE ACETABULAR REAMER WAS BENT, CAUSING UNEVEN REAMING OF THE ACETABULUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175302 ↗MalfunctionMay 14, 2026Corroded
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE PATELLAR CLAMPS WERE DEEMED UNSERVICEABLE BY HOSPITAL STERILE PROCESSING DUE TO RUST IN BETWEEN THE CUTTING GUIDE SLOT ON PATELLAR CLAMP. THE CLAMPS WERE OPENED AND REJECTED FROM THE STERILE FIELD DUE TO RUST, THIS CONSIDERED CONTAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174111 ↗MalfunctionMay 14, 2026Corroded
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE PATELLAR CLAMPS WERE DEEMED UNSERVICEABLE BY HOSPITAL STERILE PROCESSING DUE TO RUST IN BETWEEN THE CUTTING GUIDE SLOT ON PATELLAR CLAMP. THE CLAMPS WERE OPENED AND REJECTED FROM THE STERILE FIELD DUE TO RUST, THIS CONSIDERED CONTAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173749 ↗MalfunctionMay 14, 2026Corroded
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE PATELLAR CLAMPS WERE DEEMED UNSERVICEABLE BY HOSPITAL STERILE PROCESSING DUE TO RUST IN BETWEEN THE CUTTING GUIDE SLOT ON PATELLAR CLAMP. THE CLAMPS WERE OPENED AND REJECTED FROM THE STERILE FIELD DUE TO RUST, THIS CONSIDERED CONTAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173748 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE THE SP2 TIBIAL IMPACTED BROKE INTO 2 PIECES AND THE ATTUNE FEMORAL IMPACTOR BROKE AND DEVELOPED A LARGE CRACK DURING FEMORAL IMPACTING. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. ALL PIECES WHERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161884 ↗MalfunctionApr 3, 2026Break; Material Deformation
IT WAS REPORTED THAT FEMORAL IMPACTOR SCREWS WERE STRIPPED. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775890 ↗MalfunctionMar 16, 2026Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENT HAD METAL CHIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605833 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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