Orthovita, Inc., dBA Stryker Orthobiologics.: Medical Device Recall in 2013 - (Recall #: Z-1394-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 10, 2012

Date Posted: June 5, 2013

Recall Number: Z-1394-2013

Event ID: 63204

Reason for Recall:

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.

Status: Terminated

Product Quantity: 19

Code Information:

Manufacturer Part Number 2110-0506, Lot Number E909005R

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated