FDA Recall Terminated

Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.

Recall: Z-2206-2012 · Initiated July 5, 2012

Recall

Recall Number: Z-2206-2012
Event Number: 62592
Firm: Synthes USA HQ, Inc.
FEI Number: 3005180112
Product Code: MTJ
Status: Terminated
Root Cause: Labeling design
Initiated: July 5, 2012
Posted: August 16, 2012
Terminated: November 6, 2015
Address: 1302 Wrights Ln E, West Chester, PA, 19380-3417

Description

Reason

There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

Action

The firm initiated their recall of this product on July 5, 2012 by sending a "Notice: Medical Device Recall" letter to their consignees. The letter identified the affected product along with the reason for recall; and, requested that consignees immediately cease using the product, examine their inventory, and remove the product from inventory. The letter further instructed consignees to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, and to complete and return the verification form that was included with the letter. Questions should be directed to 610-719-5450.

Distribution

Worldwide Distribution -- US, including Washington, DC and states of AK, AZ, CA, CT, FL, GA, ID, KS, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI, and the country of Canada.

Quantity

8,853 packs