Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broache...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0267-2013.
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0267-2013.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medacta Usa Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0267-2013.
Medacta Usa Inc
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medacta Usa Inc Recall FAQ
Medacta Usa Inc is the subject of a medical implants safety report: Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broache.... The notice was published on October 13, 2008 by the U.S. Food and Drug Administration (FDA). Approximately 12 units are potentially affected.