[Recalled] 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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Synthes USA HQ, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2206-2012 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 05 July 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from Synthes USA HQ, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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