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

ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support o — recall Z-1917-2018

U.S. FDA — Device Enforcement · United States · 2018-03-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1917-2018
Date of alert: 2018-03-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Implant Direct Sybron Manufacturing, LLC
Product category: device
Product type: Devices

Reported risk: The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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