FDA Device recall Z-1858-2022
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site
- FDA Device
- Class II
- ongoing
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class II recall of The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site by Hologic, citing 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 expira….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1858-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-09 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hologic |
| Distribution | US |
Product
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 (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
Reason
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.
Identifiers
| code_info | UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1858-2022%22
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