BioZorb F0331Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15420045514041), received between Mar 24, 2025 and Aug 18, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K152070); 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.

Recalls naming this device

1. Oct 10, 2024Open, Classified

   Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

   Z-0328-2025 · Root cause: Device Design · FDA record ↗

2. Mar 13, 2024Open, Classified

   Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

   Z-1733-2024 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 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) 2022. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, DISCOMFORT, INFECTIONS REQUIRING TREATMENT, SWELLING, DISCHARGE, AND DEFORMITY. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Deformity/ Disfigurement; Fluid Discharge; Swelling/ Edema

  MAUDE report 22833648 ↗
• InjuryMay 27, 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 ON (B)(6) 2023. THE PATIENT REPORTS THAT SHE LATER SUFFERED FROM INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDES A HARD PAINFUL LUMP, DEFORMITY, PAIN, PALPABILITY, DISCOMFORT, INFLAMMATION, AND NON-ABSORPTION AT THE SITE OF THE BIOZORB. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Inflammation

  MAUDE report 22090881 ↗
• InjuryMar 24, 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 ON (B)(6) 2019, AFTER A LUMPECTOMY. MULTIPLE LESIONS WERE REMOVED DURING SURGERY AND AXILLARY AND STERNUM AND NECK WERE DEEMED POSITIVE. THE PATIENT WAS REPORTED TO RECEIVE CHEMOTHERAPY (PERJECTA, CAROPLATIN, HERCEPTIN, TOXOTERE, AND THE PATIENT HAD A COMPLETE RESPONSE TO CHEMO). THE PATIENT REPORTED THAT SHE EXPERIENCED PAIN DUE TO THE BIOZORB DEVICE. ADDITIONALLY, THE PATIENT REPORTED THAT SHE BELIEVES THAT IT WAS AFFECTING HER WHITE BLOOD CELL COUNT, AND THAT THE CHEMOTHERAPY WAS AFFECTING HER MUSCLE MASS. THE PATIENT ALSO REPORTED THAT SHE EXPERIENCED ALLERGIC REACTIONS AND TREATMENT FOR INFECTION AT THE WOUND SITE. ON (B)(6) 2020, THE BIOZORB WAS REMOVED WITH ALL METALLIC MARKERS.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Hypersensitivity/Allergic reaction

  MAUDE report 21678278 ↗
• InjuryMar 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2017. ON (B)(6) 2018, THE PHYSICIAN CONTACTED THE FOCAL TEAM TO DISCUSS BIOZORB BEING REMOVED, AND ON (B)(6) 2018, THE BIOZORD WAS EXPLANTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21674762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152070. One submission often covers many models, so check the product and lot details in each record.

• Z-1858-2022 · Aug 9, 2022 · Open, Classified
  The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylac