Synthes USA HQ, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2206-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: July 5, 2012

Date Posted: August 22, 2012

Recall Number: Z-2206-2012

Event ID: 62592

Reason for Recall:

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

Status: Terminated

Product Quantity: 8,853 packs

Code Information:

All lot numbers associated with the identified part numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated