The Recall Desk
LowFDA (Devices)·Z-1094-2015·Announced 2015-02-18

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.

What this means for you

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.
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: