device · product 1 of 1
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.
- Recall number
- Z-1858-2022
- Initiated
- August 09, 2022
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Hologic, Inc
- Quantity
- 233
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Incorrect or no expiration date
Inspect official wording and provenance
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.
Code information
UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.
Distribution pattern
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.