Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SB
Recalled Product
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 of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Hazard / Issue
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Issued by
FDA
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