Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and f...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0408-2014.
There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0408-2014.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
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-0408-2014.
Synthes USA HQ, Inc.
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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.
Synthes Usa Hq, Inc. Recall FAQ
Synthes Usa Hq, Inc. is the subject of a medical devices safety report: Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and f.... The notice was published on July 31, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 166 units are potentially affected.