Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and os...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2485-2012.
Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2485-2012.
Recall terminated by FDA.
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- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2485-2012.
Biomet, Inc.
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Biomet, Inc. Recall FAQ
Biomet, Inc. is the subject of a medical devices safety report: Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and os.... The notice was published on August 23, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 268 units are potentially affected.