RapidSorb 805.604.10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20887587061679), received between Jul 2, 2019 and Jul 8, 2019 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED : THE ORIGINAL SURGERY DATE WAS ON AN UNKNOWN DATE IN (B)(6) 2018.

  Patient problems: No Code Available; Reaction

  MAUDE report 8767232 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED: THE ORIGINAL SURGERY DATE WAS ON AN UNKNOWN DATE IN (B)(6) 2018.

  Patient problems: No Code Available; Reaction

  MAUDE report 8767209 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED : THE ORIGINAL SURGERY DATE WAS ON AN UNKNOWN DATE IN (B)(6) 2018.

  Patient problems: No Code Available; Reaction

  MAUDE report 8767191 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Irritation

  MAUDE report 8758093 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A SECOND SURGERY WAS PERFORMED DUE TO ALLERGIC REACTION TO THE MATERIAL UNDER THE SURGICAL SITE THAT CAUSED INFLAMMATION AND SKIN BREAKDOWN. ITEMS WERE NOT REMOVED OUT OF PATIENTS HEAD BECAUSE THEY ARE RESORBABLE AND DISSOLVE. PATIENT OPEN WOUND HAD TO BE CLEANED AND CARED FOR AND REQUIRED MORE VISITS TO THE SURGEON FOR WOUND HEALING.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Irritation

  MAUDE report 8754854 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A SECOND SURGERY WAS PERFORMED DUE TO ALLERGIC REACTION TO THE MATERIAL UNDER THE SURGICAL SITE THAT CAUSED INFLAMMATION AND SKIN BREAKDOWN. ITEMS WERE NOT REMOVED OUT OF PATIENTS HEAD BECAUSE THEY ARE RESORBABLE AND DISSOLVE. PATIENT OPEN WOUND HAD TO BE CLEANED AND CARED FOR AND REQUIRED MORE VISITS TO THE SURGEON FOR WOUND HEALING.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Irritation

  MAUDE report 8753874 ↗

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