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NA 2296003108Recalls & reported problems

Stryker Corporation · Precision Thin (13.0 x 0.38 x 39.0mm) · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540046482), received between Dec 16, 2019 and Sep 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 8, 2025Open, Classified

    Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

    Z-1138-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Fracture3

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 12, 2022Fracture; Fracture

    IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15403295 ↗
  • MalfunctionDec 16, 2019Fracture; Fracture

    IT WAS REPORTED THAT DURING A COMMANDO PROCEDURE (COMBINED MANDIBULECTOMY AND NECK DISSECTION OPERATION), TWO BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9474792 ↗
  • MalfunctionDec 16, 2019Fracture; Fracture

    IT WAS REPORTED THAT DURING A COMMANDO PROCEDURE (COMBINED MANDIBULECTOMY AND NECK DISSECTION OPERATION), TWO BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9474767 ↗

Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices

All BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.