Hologic BioZorb Markers Recall Lawsuit

The U.S. Food and Drug Administration (FDA) is alerting consumers, healthcare providers, and healthcare facilities not to use BioZorb Markers and BioZorb LP Markers. The Hologic, Inc. products have been recalled. The lawyers at Johnson//Becker, PLLC, are currently accepting new cases for recalled BioZorb Markers.

Medical Device Injuries
If a recalled medical device injured you or a loved one, you may want to speak with the lawyers at Johnson//Becker.

The FDA report indicates serious adverse events occurred in patients who had the devices implanted in breast tissue. Complications stemming from the BioZorb Markers include but are not limited to pain, infection, rash, device migration (moving out of position), device erosion (breaking through the skin), seroma (fluid buildup), and discomfort. Medical treatment and/or device removal has been needed for some patients.

BioZorb Markers are implantable devices used in soft tissue sites, including breast tissue. The BioZorb Markers are used to mark sites in soft tissue radiographically. The markers are also used in situations where the soft tissue site needs to be marked for future medical procedures. The BioZorb Markers have two parts: a plastic component that is intended to be dissolved completely in the patient’s body in one year or longer and a titanium metal component that is permanent.

Unique Device Identifier

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing though distribution to patient use. You can find the UDI provided by Hologic, Inc. for BioZorb Marker and BioZorb LP Marker devices by checking the table below.

Version or Model Device Brand Name Device Description Device Identifier (DI) Number
F0405 BioZorb Bioadsorbable Marker BioZorb Marker 4cm x 5cm 15420045514065
F0404 BioZorb Bioadsorbable Marker BioZorb Marker 4cm x 4cm 15420045514058
F0304 BioZorb Bioadsorbable Marker BioZorb Marker 3cm x 4cm 15420045514010
F0303 BioZorb Bioadsorbable Marker BioZorb Marker 3cm x 3cm 15420045514003
F0203 BioZorb Bioadsorbable Marker BioZorb Marker 2cm x 3cm 15420045513990
F0202 BioZorb Bioadsorbable Marker BioZorb Marker 2cm x 2cm 15420045513983
F0331 BioZorb LP Bioadsorbable Marker BioZorb Marker 1cm x 3cm x 3cm 15420045514041
F0231 BioZorb LP Bioadsorbable Marker BioZorb Marker 1cm x 3cm x 2cm 15420045514034
F0221 BioZorb LP Bioadsorbable Marker BioZorb Marker 1cm x 3cm x 2cm 15420045514027

Questions About a Hologic BioZorb Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review

If a recalled medical device injured you or a loved one, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new cases for recalled BioZorb Markers nationwide, and you may be entitled to financial compensation.

We offer a Free Case Evaluation. Please use the form below to contact us or call (800) 279-6386. We would be honored to speak with you and respond promptly to every inquiry.

Free Case Evaluation

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