Recall Z-2206-2012— Synthes USA HQ, Inc.

Name: FDA recall Z-2206-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-05

Class I · Terminated

Class I FDA medical device recall by Synthes USA HQ, Inc., initiated 2012-07-05, terminated 2015-11-06. It names 2 FDA 510(k) clearances: K113079, K103822. Product: 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.. Reason: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-07-05
Terminated: 2015-11-06
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K113079 — SYNTHES HEMOSTATIC BONE PUTTYSynthes (Usa) Products, LLC/Norian Corporation·cleared 2011-12-13
K103822 — SYNTHES HEMOSTATIC BONE PUTTY (HBP)Synthes USA Products, LLC·cleared 2011-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.