Synthes Recalls Hemostatic Bone Putty Due to Incorrect Brochure Revision
Synthes, Inc. is recalling 38 units of Hemostatic Bone Putty because Revision A of the brochure was distributed instead of the corrected Revision B.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation error (incorrect brochure revision) rather than a product defect or safety hazard, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Synthes, Inc. is recalling 38 units of Hemostatic Bone Putty, a water-soluble implant material used to control bleeding from bone surfaces. The recall is limited to the state of Wisconsin.
The recall was initiated because Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B). Revision B contained a correction to an error in the indication statement. The affected product is identified by Part 10847A.
No specific instructions for consumers are provided in the source text, as the distribution was limited to sales consultants.
The recalled product
- Product
- Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
- Manufacturer
- Synthes, Inc.
- Category
- Medical Device — Bone Implant
- Hazard
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part 10847A
Distribution
Distributed in 1 state:
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