Recall Z-1094-2015— Synthes, Inc.

Name: FDA recall Z-1094-2015
Creator: U.S. Food and Drug Administration
Published: 2012-01-06

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2012-01-06, terminated 2015-03-30. It names one FDA 510(k) clearance: K113079. Product: Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.. Reason: 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..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-01-06
Terminated: 2015-03-30
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113079 — SYNTHES HEMOSTATIC BONE PUTTYSynthes (Usa) Products, LLC/Norian Corporation·cleared 2011-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.