Hologic BioZorb Bioabsorbable Markers Recalled for Adverse Events
Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The recall involves reported adverse events including infection, device migration, device erosion, and need for medical intervention.
Plain-English summary
Hologic, Inc. is recalling BioZorb Marker bioabsorbable markers across nine different models and sizes. These devices are used to mark sites in soft tissue during radiographic procedures. The recall affects approximately 53,492 units distributed nationwide, including all lots and both implanted and non-implanted devices within their expiration date.
The FDA has classified this recall as Class I due to reported adverse events associated with the devices. Complaints describe complications including pain, infection, rash, device migration, device erosion, seroma, and discomfort from feeling the device in breast tissue. Some patients have required additional medical treatment to remove the device.
Patients who have received these markers should contact their healthcare provider if they experience any symptoms or complications. Healthcare providers should monitor patients and consider device removal if adverse events occur.
The recalled product
- Product
- 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…
- Manufacturer
- Hologic, Inc
- Affected units
- 53,492
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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.
Distribution
Distributed nationwide across the United States.
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