Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1858-2022 — 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). The BioZorb LP Mark

U.S. FDA — Device Enforcement · United States · 2022-08-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1858-2022
Date of alert: 2022-08-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hologic, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15420045514027

Reported risk: Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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