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

Recall Z-0561-2013 — AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

U.S. FDA — Device Enforcement · United States · 2012-11-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0561-2013
Date of alert
2012-11-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
BioHorizons Implant Systems Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
02070051
Reported risk: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
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.

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