RapidSorb 852.264.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587064307), received between Oct 7, 2024 and Oct 7, 2024 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NONE OF THE PATIENTS EXPERIENCED ADVERSE EVENTS SUCH AS MAXILLARY SINUSITIS OR OBVIOUS NONUNION. THERE WAS ONE CASE OF PLATE FRACTURE. THE LOT NUMBERS WERE PLATE 6L87402, 6L71797, 6L58763, 6L39795 AND SCREW 4L95040. THE FRACTURED FRAGMENTS HAVE ALREADY BEEN PROCESSED AND ARE NO LONGER PRESENT. THE SLIGHT POSTOPERATIVE DEVIATION BY FIXATION WITH FOUR RAPIDSORB PLATES IS DUE TO THE TOOTH BEING SOMEWHAT VULNERABLE TO OCCLUSAL LOADS, AND WE BELIEVE THIS IS DUE TO A DECREASE IN THE GRIPPING STRENGTH OF THE SCREW CAUSED BY SLIGHT WOBBLING DURING TAPPING.

  Patient problems: Physical Asymmetry

  MAUDE report 20384210 ↗

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-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