Recall Z-1858-2022 ยท NEU Marker, Radiographic, Implantable
Hologic, Inc
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.
| Date | Sep 30, 2022 (initiated Aug 9, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Incorrect or no expiration date |
| Action | On August 9, 2022, the recalling firm sent out recall letters with subject line "RE: Incorrect expiration date on BioZorb bioabsorbable marker removable label". Customers were instructed to return any unused product from the affected lot to Hologic. Please contact BSHCustomersupport@hologic.com with the number of unused units from Lot#22A20RL that you have. You will be provided a pre paid label to facilitate return. You will also be issued a credit on your account for the returned product. If you wish to reorder product, please place a new order via your preferred procurement method. If mat |
| Quantity | 233 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152070 | BioZorb LP Marker Focal Therapeutics, Aug 26, 2015 |