BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ
Summary
The FDA issued a Class I for BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking by Hologic, Inc. Reason: Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, dis.
Details
Source
Device Recall
External ID
Z-1733-2024
Action Date
2024-05-15
Status
Ongoing
Category
device
Product Description
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
Lot/Code Info: UDI-DI: (1) 15420045514065; (2) 15420045514058; (3) 15420045514041; (4) 15420045514034; (5) 15420045514027; (6) 15420045514010; (7) 15420045514003; (8) 15420045513990; (9) 15420045513983. All lots, including implanted devices and non-implanted devices within expiration date.
Quantity Affected: 53492
Reason for Recall
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-13
Company
Marlborough, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 151 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hologic, Inc has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hologic, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hologic, Inc have FDA actions?
Hologic, Inc has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1733-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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