The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The Bi

FDA device recall Z-1858-2022 · posted 2022-09-30 · Open, Classified

Recall details

Recalling firm

Hologic, Inc

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.

Action taken

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 material has already been implanted from the affected lot and the patient chart requires updating, Hologic included corrected labels with the recall letter for that purpose.

Root cause

Incorrect or no expiration date

Status

Open, Classified

Product code

NEU

Quantity affected

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.

Date initiated

2022-08-09

Date posted

2022-09-30

Location

Marlborough, MA

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