StratumRecalls & reported problems across all models
Medartis Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 5 models of Stratum by Medartis Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2019 and Jan 7, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (3 reports).
4 FDA recall records 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
Stratum 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 11, 2019Terminated
Components 2mm shorter than indicated on the package label
Z-0778-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Nov 11, 2019Terminated
Components 2mm shorter than indicated on the package label
Z-0777-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Nov 11, 2019Terminated
Components 2mm shorter than indicated on the package label
Z-0776-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Oct 9, 2019Terminated
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Z-0534-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Stratum problems
Device problems
- Inaccurate Information3
- Device Markings/Labelling Problem1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- Not Applicable1
Stratum models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stratum STRM-NL-3550STScrew, Fixation, Bone1 recall1 report
- Stratum STRM-MDS-3546STScrew, Fixation, Bone1 recall0 reports
- Stratum STRM-MDS-3548STScrew, Fixation, Bone1 recall0 reports
- Stratum STRM-MDS-3550STScrew, Fixation, Bone1 recall0 reports
- Stratum STRM-LAP-SMRPlate, Fixation, Bone2 reports
Recent Stratum adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2020Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT A STRATUM FOOT PLATING SYSTEM STRM-LAP-SMR (STRATUM LAPIDUS PLATE -SMALL RT) PACKAGE WAS FOUND TO CONTAIN AN STRM-LAP-SML (STRATUM LAPIDUS PLATE - SMALL LT). THE INCORRECT PLATE WAS DISCOVERED BY A SALES REPRESENTATIVE PRIOR TO THE SCHEDULED SURGERY. A REPLACEMENT STRM-LAP-SMR PLATE WAS OBTAINED. THERE WAS NO AFFECT ON THE SURGERY OR THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9559896 ↗MalfunctionDec 20, 2019Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT A STRATUM FOOT PLATING SYSTEM STRM-LAP-SMR (STRATUM LAPIDUS PLATE - SMALL RT) PACKAGE WAS OPENED AND FOUND TO CONTAIN A STRM-LAP-SML (STRATUM LAPIDUS PLATE - SMALL LT). THE SURGEON SELECTED AN ALTERNATE PLATE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9505713 ↗MalfunctionOct 17, 2019Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information
WHILE BUILDING A STRATUM FOOT PLATING SYSTEM SET, A SALES REPRESENTATIVE SELECTED A SCREW LABELED AS STRM-NL-3550ST AND NOTICED THE PRODUCT IN THE PACKAGE DID NOT MATCH THE INFORMATION ON THE LABEL. THE SCREW IN THE PACKAGE WAS VISIBLY A SHORTER LENGTH AND A DIFFERENT TYPE OF SCREW.
Patient problems: Not Applicable
MAUDE report 9205308 ↗
Other Medartis Inc. products
All Medartis Inc. 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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