BioZorb LP Marker F0221Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851766006061), received between Sep 5, 2023 and Jun 30, 2025 — classified as 5 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2020. FURTHER REPORTED IS THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, SLEEP DYSFUNCTION, DEFORMITY, SCARRING, A HARD PAINFUL LUMP, SENSITIVITY, IRRITATION, AND FAILURE TO ABSORB. IT IS REPORTED THAT THE BIOZORB DEVICE WAS REMOVED ON OR AROUND (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 22364941 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 77-YEAR-OLD PATIENT, RECEIVED A BIOZORB (F0221) ON (B)(6) 2020, DURING A LUMPECTOMY DUE TO AN INFILTRATING LOBULAR CARCINOMA, GRADE2, ER/PR+, HER-2 NEGATIVE AND NODE NEGATIVE. PATIENT RECEIVED ANTIBIOTICS PRE-SURGERY. PATIENT HAD NORMAL POST OP VISITS UNTIL ON (B)(6) 2020 IN WHICH THE PATIENT PRESENTED TO THE PHYSICIAN´S OFFICE WITH A RASH AFFECTING HER ENTIRE RIGHT BREAST IT IS UNKNOWN WHEN IT STARTED. IRRITATION SPREAD THROUGHOUT MOST OF HER BODY AND PATIENT WOULD DESCRIBE IT AS AN ALLERGIC REACTION. PATIENT HAD ALREADY SEEN HER PRIMARY PHYSICIAN AND WAS GIVEN (VISTARIL) ANTIHISTAMINIC BECAUSE SHE WAS NOT TOLERANT OF ORAL STEROIDS. THE TREATMENT WAS NOT CHANGED BUT SHE WAS REFERRED TO AN ALLERGIST. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 20758661 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A BIOZORB PROCEDURE WAS PERFORMED, AND THE PATIENT REPORTED SUFFERS FROM PAIN, SORENESS, SWELLING, AND DISCOMFORT AT AND NEAR THE AREA WHERE THE BIOZORB DEVICE WAS IMPLANTED, WHICH MAKES IT DIFFICULT TO SLEEP. THE PATIENT REPORTED TO DEVELOPED A CYST AROUND THE BIOZORB DEVICE, CAUSING FURTHER PAIN AND SUFFERING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Cyst(s); Erythema; Swelling/ Edema

  MAUDE report 17881491 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB IN (B)(6) 2020. THE PATIENT IS REPORTING THAT SHE IS SUFFERING FROM PAIN, ITCHING, REDNESS, TENDERNESS AND DEFORMITY ON HER LEFT BREAST. PATIENT IS ALSO REPORTING THAT SHE HAS HAD TROUBLE SLEEPING . NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Itching Sensation; Sleep Dysfunction

  MAUDE report 17685154 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED THAT SUFFERS FROM A HARD, PALPABLE LUMP AT THE SITE OF THE BIOZORB, ALSO REPORTED THAT SUFFERS FROM CONSTANT, SEVERE PAIN, TENDERNESS, SENSITIVITY, AND DISCOMFORT IN THE AREA OF THE DEVICE, PAIN WHEN SLEEPING ON HER LEFT SIDE AND SUFFERS FROM PAIN ANY TIME SHE NEEDS TO MOVE HER HAND AND ARM ABOVE HER SHOULDERS, SEVERELY LIMITING HER MOBILITY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Sleep Dysfunction

  MAUDE report 17684330 ↗