medical HIGH RISK Updated 2024-05-15

Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use

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Recalled 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 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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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