Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock P...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2677-2014.
The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2677-2014.
Recall terminated by FDA.
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Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- 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-2677-2014.
Genesys Orthopedics Systems, LLC
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Genesys Orthopedics Systems, Llc Recall FAQ
Genesys Orthopedics Systems, Llc is the subject of a medical devices safety report: Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock P.... The notice was published on April 2, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 642 units are potentially affected.