Z-1094-2015Class II

Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding...

Name: Z-1094-2015 Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding...
Creator: Synthes, Inc.
Published: 2012-01-06
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-01-06 / Terminated / root cause: labeling and UDI

FDA source

Synthes, Inc. began a recall of Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces on 2012-01-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1094-2015
Classification: Class II
Status: Terminated
Initiated: 2012-01-06
Posted: 2015-02-11
Terminated: 2015-03-30
Recalling firm: Synthes GmbH
Product: Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Product code: MTJ Wax, Bone
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On/about 12/22/2011, emails containing Revision B brochure, as well as instructions to delete/destroy Revision A, were sent to 38 affected individuals (sales consultants). On/about 1/04/2012, follow up phone calls were made to each member of the sales force who had received Rev. A (110847 A) to confirm that they had replaced the Rev. A with the Rev. B (110847 B). In addition, the members of the sales force were asked whether or not the Rev. A had been disseminated to any HCP's. During the follow up conversation, one member of the sales force stated that he had provided the previous version to a surgeon. On 01/06/2012, the sales consultant spoke to the surgeon in person and the surgeon confirmed that he had disposed of the Rev. A.
Quantity in commerce: 38
Distribution: Distributed in the state of WI
Product codes and lots: Part 10847A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1094-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1094-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11

Product code MTJ

K113079UnclassifiedSynthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation / cleared 2011-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)