RapidSorb 852.004.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587064253), received between Jun 9, 2025 and Dec 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K030069, K062789); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW'S BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791138 ↗
• MalfunctionJun 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW BROKE DURING INSERTION. DUE TO THE SCREW BREAKAGE, THE PLATE CANNOT BE USED NORMALLY, THERE IS NO QUALITY PROBLEM WITH THE PLATE ITSELF. IT WAS CHANGED WITH ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167864 ↗
• MalfunctionJun 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW BROKE DURING INSERTION. DUE TO THE SCREW BREAKAGE, THE PLATE CANNOT BE USED NORMALLY, THERE IS NO QUALITY PROBLEM WITH THE PLATE ITSELF. IT WAS CHANGED WITH ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167807 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030069, K062789. One submission often covers many models, so check the product and lot details in each record.

• Z-1919-2016 · May 2, 2016 · Terminated
  1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intend
• Z-1918-2016 · May 2, 2016 · Terminated
  1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Inte
• Z-1920-2016 · May 2, 2016 · Terminated
  1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intend