RapidSorb 805.605.04SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20887587061709), received between Nov 27, 2018 and Jul 2, 2019 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 8753632 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1/4/2019. UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT ORIGINALLY UNDERWENT (ORIF) OPEN REDUCTION INTERNAL FIXATION USING SYNTHES RAPID ABSORBING PLATE SYSTEM DUE TO COMMINUTED TRIPOD FRACTURE ON (B)(6) 2018. THE 1.5MM RAPID RESORBABLE ORBITAL RIM PLATE, 2.0MM RAPID RESORBABLE Y-PLATE, TWO (2) 1.5MM RAPID RESORBABLE CORTEX SCREW, TWO (2) 2.0MM RAPID RESORBABLE CORTEX SCREW, AND 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS WAS IMPLANTED DURING A LEFT (ZYGOMATICOMAXILLARY COMPLEX ZMC) FRACTURE REPAIR. AFTER SIX MONTHS, PATIENT WAS COMPLAINING OF TENDERNESS AND SLIGHTLY PALPABLE AT THE SURGERY SITE. NO REVISION SURGERY WILL BE PERFORMED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.

  Patient problems: Skin Irritation

  MAUDE report 8108157 ↗

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-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
• 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