Hologic BioZorb LP Implant Markers Recalled Due to Mislabeled Expiration Date
Hologic recalls 233 BioZorb LP Markers nationwide due to removable labels showing incorrect expiration dates. Implants labeled with January 2022 dates may be mistakenly used after their actual July 2024 expiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving mislabeled expiration dates on an implantable medical device. While no illnesses or injuries have been reported, the mislabeling creates a direct risk of harm by potentially allowing use of expired devices, fitting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hologic, Inc. is recalling 233 BioZorb LP Markers, sterile implantable radiopaque markers used to mark soft tissue sites during procedures. The device consists of a bioabsorbable polylactic acid component that resorbs within one year or more and a permanent titanium component.
The recall was initiated because removable labels on lot 22A0RL display an incorrect expiration date of January 20, 2022, which is actually the manufacturing date. The correct expiration date of July 8, 2024, appears on the shelf box label, creating potential for inadvertent use of expired devices based on the incorrect removable label date.
The affected devices were distributed nationwide across multiple U.S. states, including Florida, Illinois, Maryland, New Jersey, Arizona, Texas, Washington, Virginia, Oklahoma, North Carolina, New Hampshire, Georgia, California, Connecticut, Ohio, Colorado, Michigan, Missouri, Kansas, Tennessee, Idaho, Mississippi, Montana, Alabama, Oregon, Iowa, and Pennsylvania.
Healthcare providers should verify the correct expiration date using the shelf box label rather than the removable label. Any units from lot 22A0RL should not be implanted if the actual expiration date has passed.
The recalled product
- Product
- The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium).
- Manufacturer
- Hologic, Inc
- Hazard
- mislabeling
- expired-device-risk
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 (4)
- UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8
- 2024
- but incorrect labels state expiration date of January 20
- 2022.
Distribution
Distributed nationwide across the United States.
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