RapidSorb 805.606.02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20887587061723), received between Jul 8, 2019 and Feb 22, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN ORIF SURGERY TREATING ZYGOMATIC FRACTURE PERFORMED ON (B)(6) 2021, WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. FROM ABOUT 3 MONTHS AFTER SURGERY, SWELLING AND DISAPPEARANCE OF THE CHEEK ON THE AFFECTED SIDE HAVE BEEN REPEATED. AT FIRST, THE SURGEON THOUGHT THE SYMPTOM WAS A FOREIGN BODY REACTION CAUSED BY AN ABSORBABLE PLATE AND DECIDED TO CONTINUE TO FOLLOW UP UNTIL THE PLATE WAS ABSORBED. HOWEVER, THE SYMPTOM HAS BEEN PERSISTING 1 YEAR AND 5 MONTHS AFTER THE SURGERY. THE SURGEON COMMENTED THAT THE CLINICAL SYMPTOM WAS SUSPECTED TO BE ANGIOEDEMA (QUINCKE'S EDEMA). THIS REPORT IS FOR A 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 16419087 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN ORIF SURGERY TREATING ZYGOMATIC FRACTURE PERFORMED ON (B)(6) 2021, WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. FROM ABOUT 3 MONTHS AFTER SURGERY, SWELLING AND DISAPPEARANCE OF THE CHEEK ON THE AFFECTED SIDE HAVE BEEN REPEATED. AT FIRST, THE SURGEON THOUGHT THE SYMPTOM WAS A FOREIGN BODY REACTION CAUSED BY AN ABSORBABLE PLATE AND DECIDED TO CONTINUE TO FOLLOW UP UNTIL THE PLATE WAS ABSORBED. HOWEVER, THE SYMPTOM HAS BEEN PERSISTING 1 YEAR AND 5 MONTHS AFTER THE SURGERY. THE SURGEON COMMENTED THAT THE CLINICAL SYMPTOM WAS SUSPECTED TO BE ANGIOEDEMA (QUINCKE'S EDEMA). THIS REPORT IS FOR A 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 16419078 ↗
• 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 8767164 ↗

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