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 Mark
Check against the official notice below — it lists the full affected range.
Hologic, Inc. is recalling 233 units of the BioZorb LP Marker (Product number F0221, lot number 22A0RL), an implantable radiopaque marker used to help visualize soft tissue sites during medical procedures. The recalled devices contained removable labels showing an incorrect expiration date of January 20, 2022, which is actually the manufacturing date. The correct expiration date printed on the shelf box label is July 8, 2024. The affected devices were distributed nationwide across 28 states.
The recall was issued because the misleading expiration date on the removable label could cause healthcare providers to believe the product had already expired and should not be used. The source document does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA. Quantity: 233 Lot/code info: UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.