Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Synthes(R) Hemostatic Bone Putty Recalled by Synthes USA HQ, Inc. Due to There is the potential for Hemostatic Bone Putty...

Date: July 5, 2012
Company: Synthes USA HQ, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Synthes USA HQ, Inc. directly.

Affected Products

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.

Quantity: 8,853 packs

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 27 states: 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, WI, DC

Affected (27 states)Not affected

About Synthes USA HQ, Inc.

Synthes USA HQ, Inc. has 56 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report