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

FDA device recall Z-1094-2015 · posted 2015-02-11 · Terminated

Recall details

Recalling firm

Synthes, Inc.

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

MTJ

Quantity affected

38

Distribution

Distributed in the state of WI

Date initiated

2012-01-06

Date posted

2015-02-11

Date terminated

2015-03-30

Location

West Chester, PA

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