Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.1

FDA device recall Z-2206-2012 · posted 2012-08-16 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

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

Action taken

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.

Root cause

Labeling design

Status

Terminated

Product code

MTJ

Quantity affected

8,853 packs

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 Cana

Date initiated

2012-07-05

Date posted

2012-08-16

Date terminated

2015-11-06

Location

West Chester, PA

Related 510(k) clearances