FDA Device recall Z-2206-2012
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 u…
- FDA Device
- Class I
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class I recall of 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 u… by Synthes Usa Hq, citing there is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2206-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-07-05 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | AK, AZ, CA, CT, DC, FL, GA, ID, KS, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, OH, OR, PA, SC, TX, VA, WA, WI |
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.
Identifiers
| code_info | All lot numbers associated with the identified part numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2012%22
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