Synthes — Class I medical device recall Z-2206-2012
Terminated recall by Synthes USA HQ, Inc., reported 2012-08-22, distributed in AK, AZ, CA, CT, DC, FL, GA, ID…. There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems u
| Recall number | Z-2206-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2012-07-05 |
| Classified | 2012-08-16 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2015-11-06 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 8,853 packages |
| Model numbers | 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, VB1025.10S |
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 for recall
There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2206-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.