Tritanium TLRecalls & reported problems across all models
Stryker Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 6 models of Tritanium TL by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2018 and Apr 13, 2026 — classified as 2 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (20 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. 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
Most reported Tritanium TL problems
Device problems
- Mechanical Jam20
- Fracture6
- Difficult to Remove4
- Difficult to Insert3
- Defective Device1
- Detachment of Device or Device Component1
- Malposition of Device1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- Injury1
- No Patient Involvement1
Tritanium TL models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tritanium TL 48930000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT12 reports
- Tritanium TL 48930005ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- Tritanium TL 48932092Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium TL 48930106Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium TL 48932010ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Tritanium TL 48930013ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Tritanium TL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Mechanical Jam
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISM ON A TRITANIUM TL STEERABLE INSERTER WAS JAMMING DURING CAGE INSERTION INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867571 ↗MalfunctionDec 22, 2025Difficult to Insert; Difficult to Remove; Mechanical Jam; Difficult to Insert; Difficult to Remove; Mechanical Jam
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874056 ↗MalfunctionDec 22, 2025Difficult to Insert; Difficult to Remove; Mechanical Jam; Difficult to Insert; Difficult to Remove; Mechanical Jam
IT WAS REPORTED THAT A TRITANIUM TL STEERABLE INSERTER AND A TRITANIUM TL STEERABLE INSERTER SHAFT WERE JAMMING INTRA-OPERATIVELY AND WERE UNABLE TO INSERT A CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING DIFFERENT INSTRUMENTS WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874055 ↗MalfunctionDec 9, 2025Fracture; Difficult to Insert; Mechanical Jam; Fracture; Difficult to Insert; Mechanical Jam
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764365 ↗MalfunctionNov 3, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23447289 ↗MalfunctionDec 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING CAGE INSERTION A TRITANIUM CURVED POSTERIOR LUMBAR CAGE BECAME JAMMED AND REMAINED STUCK TO A TRITANIUM STEERABLE INSERTER AND A TRITANIUM STEERABLE INSERTER SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT CAGE WITH A 25 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE TRITANIUM STEERABLE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18311293 ↗MalfunctionDec 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING CAGE INSERTION A TRITANIUM CURVED POSTERIOR LUMBAR CAGE BECAME JAMMED AND REMAINED STUCK TO A TRITANIUM STEERABLE INSERTER AND A TRITANIUM STEERABLE INSERTER SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT CAGE WITH A 25 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE TRITANIUM STEERABLE INSERTER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18311286 ↗MalfunctionDec 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING CAGE INSERTION A TRITANIUM CURVED POSTERIOR LUMBAR CAGE BECAME JAMMED AND REMAINED STUCK TO A TRITANIUM STEERABLE INSERTER AND A TRITANIUM STEERABLE INSERTER SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT CAGE WITH A 25 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE TRITANIUM CURVED POSTERIOR LUMBAR CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18311276 ↗MalfunctionNov 15, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam
A COMPANY REPRESENTATIVE REPORTED THAT DURING INSERTION, THE TRITANIUM TL STEERABLE INSERTER INNER SHAFT WOULD NOT RELEASE THE TRITANIUM TL CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DEVICE WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE TRITANIUM TL STEERABLE INSERTER INNER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145342 ↗MalfunctionOct 28, 2022Mechanical Jam; Mechanical Jam
THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE TRITANIUM TL STEERABLE INSERTER INNER SHAFT JAMMING. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15691427 ↗MalfunctionOct 28, 2022Mechanical Jam; Mechanical Jam
THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE TRITANIUM TL INSERTER JAMMING. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15691152 ↗MalfunctionSep 14, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT WHILE INSERTING A TLIF CAGE DURING A LUMBAR ARTHRODESIS, THE TIP OF A TRITANIUM TL STEERABLE INSERTER SHAFT BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15422122 ↗MalfunctionJul 29, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE IMPACTING A CAGE, THE TRITANIUM PL STEERABLE INSERTER INSIDE SHAFT BROKE INTRA-OPERATIVELY AFTER SEVERAL BLOWS OF THE MALLET. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15135572 ↗InjuryMar 23, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT AFTER INTRA-OPERATIVE PLACEMENT OF A TRITANIUM TL CAGE, THE IMPLANT 'DROPPED INTO THE BODY'. A SECOND SURGICAL INCISION WAS NEEDED IN ORDER TO RETRIEVE THE IMPLANT. AFTER RETRIEVAL THE ORIGINAL IMPLANT WAS PLACED AGAIN AND REMAINS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13870016 ↗MalfunctionJan 17, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT A TRITANIUM TL INSERTION REMOVAL TOOL "NO LONGER HOLDS THE IMPLANT AND CANNOT BE DISASSEMBLED" INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN 8 MINUTE SURGICAL DELAY. THIS RECORD CAPTURES THE INSERTION REMOVAL TOOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13267551 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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