FDAFDA · Food and drugs·Recall number Z-0062-2015
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Published October 15, 2014 · Recall initiated: September 19, 2014
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
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthohelix Surgical Designs Inc
- Distributor
- USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
- Lot
- Part Number: MFT-074-CC-24; Lot: 3164011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.