BioZorb LP Marker
by Focal Therapeutics 510(k)
Active Open recall
510(k) K152070
Regulatory status
Recall ongoing. 3 ongoing FDA recalls name this device. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152070 | Date26 Aug 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Ongoing Z-0328-2025
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
-
- Ongoing Z-1733-2024
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
-
- Ongoing Z-1858-2022
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.
Specification
- 510(k) Number
- FDA Product Code
- NEU
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent