FDAFDA · Food and drugs·Recall number Z-0789-2013
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Published February 13, 2013 · Recall initiated: November 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Distributor
- Worldwide Distribution - USA including California and Internationally to Spain and Korea
- Lot
- Lot 256058
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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