—#111111

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.

FDA product code: MTJ — Wax, Bone
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K103822, K113079
Affected lot / code info: All lot numbers associated with the identified part numbers.

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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.

Timeline

Recall initiated: 2012-07-05
Posted by FDA: 2012-08-16
Terminated: 2015-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.