Tritanium PLRecalls & reported problems across all models
Stryker Corporation · 45 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 130
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls
- 1
We found 45 models of Tritanium PL by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2016 and Sep 21, 2026 — classified as 51 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Fracture” (69 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
Tritanium PL 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.
- Nov 28, 2018Terminated
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Z-0605-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Tritanium PL problems
Device problems
- Fracture69
- Migration45
- Break32
- Migration or Expulsion of Device10
- Device Dislodged or Dislocated8
- Material Integrity Problem8
- Material Deformation4
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- No Known Impact Or Consequence To Patient44
- No Clinical Signs, Symptoms or Conditions35
- Injury25
- Pain20
- No Consequences Or Impact To Patient19
- Insufficient Information6
- No Code Available6
- Failure of Implant4
Tritanium PL models
45 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tritanium PL 48954076Intervertebral fusion device with bone graft, lumbar1 recall4 reports
- Tritanium PL 48955106Intervertebral fusion device with bone graft, lumbar13 reports
- Tritanium PL 48955096Intervertebral fusion device with bone graft, lumbar10 reports
- Tritanium PL 48950096Intervertebral fusion device with bone graft, lumbar9 reports
- Tritanium PL 48950116Intervertebral fusion device with bone graft, lumbar9 reports
- Tritanium PL 48953090Intervertebral fusion device with bone graft, lumbar8 reports
- Tritanium PL 48951096Intervertebral fusion device with bone graft, lumbar5 reports
- Tritanium PL 48950086Intervertebral fusion device with bone graft, lumbar4 reports
- Tritanium PL 48950106Intervertebral fusion device with bone graft, lumbar4 reports
- Tritanium PL 48955126Intervertebral fusion device with bone graft, lumbar4 reports
- Tritanium PL 48954116Intervertebral fusion device with bone graft, lumbar3 reports
- Tritanium PL 48955086Intervertebral fusion device with bone graft, lumbar3 reports
- Tritanium PL 48955116Intervertebral fusion device with bone graft, lumbar3 reports
- Tritanium PL 48950102Intervertebral fusion device with bone graft, lumbar3 reports
- Tritanium PL 48950076Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48950100Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48950110Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48951076Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48951106Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48951126Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48954096Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48954106Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48954126Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48955076Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48950092Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48950132Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48951102Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48956096Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48953112Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48953132Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48953122Intervertebral fusion device with bone graft, lumbar2 reports
- Tritanium PL 48951086Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48951136Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48952080Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48953070Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48953080Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48954086Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48955136Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48955166Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48956106Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48956136Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48956112Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48953092Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48953142Intervertebral fusion device with bone graft, lumbar1 report
- Tritanium PL 48956116Intervertebral fusion device with bone graft, lumbar1 report
Recent Tritanium PL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50849166 ↗InjurySep 21, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50849157 ↗InjurySep 8, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50680250 ↗InjurySep 8, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50680248 ↗MalfunctionMar 5, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519739 ↗MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED 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 24020694 ↗MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED 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 24020692 ↗MalfunctionDec 16, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824527 ↗InjuryNov 21, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622580 ↗InjuryJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REMOVE A TRITANIUM PL CAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22481574 ↗MalfunctionJul 10, 2025Fracture; Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY. THE FRACTURED COMPONENTS WERE REMOVED FROM THE PATIENT, RESULTING IN A 30-60 MINUTE SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22475056 ↗InjuryMay 21, 2025Migration; Migration
IT WAS REPORTED THAT ONE TRITANIUM POSTERIOR LUMBAR CAGE BECAME JAMMED AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT INTRA-OPERATIVELY, AND THAT A SECOND TRITANIUM POSTERIOR LUMBAR CAGE MIGRATED INTRA-OPERATIVELY, "PARTIALLY ENTERED THE VERTEBRAL BODY", AND WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY BY INSERTING A THIRD CAGE LATERAL FROM THE INITIAL APPROACH. THIS REPORT IS FOR THE CAGE THAT MIGRATED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22063405 ↗InjuryMay 21, 2025Difficult to Insert; Mechanical Jam; Difficult to Insert; Mechanical Jam
IT WAS REPORTED THAT ONE TRITANIUM POSTERIOR LUMBAR CAGE BECAME JAMMED AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT INTRA-OPERATIVELY, AND THAT A SECOND TRITANIUM POSTERIOR LUMBAR CAGE MIGRATED INTRA-OPERATIVELY, "PARTIALLY ENTERED THE VERTEBRAL BODY", AND WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY BY INSERTING A THIRD CAGE LATERAL FROM THE INITIAL APPROACH. THIS REPORT IS FOR THE CAGE THAT BECAME JAMMED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22061045 ↗MalfunctionApr 22, 2025Migration; Migration
IT WAS REPORTED THAT A TRITANIUM PL CAGE MIGRATED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THE PATIENT EXPERIENCED NO SYMPTOMS AND WILL NOT BE REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887194 ↗MalfunctionApr 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT A TITANIUM PL CAGE DEFORMED DURING INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT WITH A TWO MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21853273 ↗
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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