Hemostatic Bone Putty — Class II medical device recall Z-1094-2015
Terminated recall by Synthes, Inc., reported 2015-02-18, distributed in WI. Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B
| Recall number | Z-1094-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2012-01-06 |
| Classified | 2015-02-11 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-03-30 |
| Distributed | WI |
| Quantity | 38 |
| Model numbers | 10847A |
Product
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Reason for recall
Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.
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-1094-2015. 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.