FDAFDA · Food and drugs·Recall number Z-1394-2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Published June 5, 2013 · Recall initiated: November 10, 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
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Distributor
- USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
- Lot
- Manufacturer Part Number 2110-0506, Lot Number E909005R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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