RapidSorb 851.002.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587063584), received between Sep 14, 2023 and Sep 14, 2023 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K030069); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Inaccurate Information; Inaccurate Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE LABEL ON THE OUTER PACKAGE OF THE PRODUCT WAS WRONG ON (B)(6) 2023. THE PRODUCT IS A 1.5MM THICK PLATE, SO THE LABEL SHOULD HAVE BEEN RED, BUT A BLUE LABEL FOR 2.0MM THICK PLATE WAS PUT ON. THE PRODUCT WAS DELIVERED TO THE HOSPITAL FOR THE SURGERY SCHEDULED FOR (B)(6) 2023. THE EVENT WAS DISCOVERED AT THE TIME OF THE DELIVERY TO THE HOSPITAL, BEFORE SURGERY. THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.5MM RAPID RESORBABLE STRAIGHT PLATE 2 HOLES-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030069. 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-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
• 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