Recall Z-2206-2012 ยท MTJ Wax, Bone
Synthes USA HQ, Inc.
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.
| Date | Aug 16, 2012 (initiated Jul 5, 2012) |
| Status | Terminated |
| Reason | There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 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 Canada. |
| FDA record | Open on fda.gov |