RapidSorb 851.110.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587063645), received between Nov 27, 2018 and Nov 27, 2018 — classified as 2 injuries.

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

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

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT (ORIF) OPEN REDUCTION INTERNAL FIXATION USING SYNTHES RAPID ABSORBING PLATE SYSTEM, DUE TO COMMINUTED TRIPOD FRACTURE OF LEFT ZYGOMATICOMAXILLARY COMPLEX (ZMC). 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 ONE (1) 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. INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES. PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) 1.5MM RAPID RESORBABLE ORBITAL RIM PLATE. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Skin Irritation

  MAUDE report 8108298 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT (ORIF) OPEN REDUCTION INTERNAL FIXATION USING SYNTHES RAPID ABSORBING PLATE SYSTEM, DUE TO COMMINUTED TRIPOD FRACTURE OF LEFT ZYGOMATICOMAXILLARY COMPLEX (ZMC). 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 ONE (1) 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. INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES. PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Skin Irritation

  MAUDE report 8108043 ↗

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-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