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Title: Synthes Hemostatic Bone Putty Recalled Due to Fire Hazard
Source: [None]
URL Source: http://www.medscape.com/viewarticle/769522
Published: Aug 21, 2012
Author: Robert Lowes
Post Date: 2012-08-24 04:54:25 by Tatarewicz
Keywords: None
Views: 6

August 21, 2012 — Synthes, a unit of Johnson & Johnson, has recalled its hemostatic bone putty (HBP) product because it can catch on fire if it touches electrosurgical cautery systems under some surgical conditions, the US Food and Drug Administration (FDA) announced today.

HBP is a water-soluble material approved by the FDA to stop bone bleeding that results from trauma or a cut during a surgical procedure. HBP forms a barrier that blocks vascular openings in the damaged bone and then dissolves after the operation.

This class 1 recall, which is the most serious type of recall and indicates use of the product could cause serious adverse health consequences or death, applies to all lots of the following part numbers:

08.901.001.97S 08.901.001.98S 08.901.001.99S 08.901.001D VB1025.10S

The recalled HBP was manufactured between July 6, 2011, and December 14, 2011, and distributed between December 22, 2011, and June 25, 2012.

On July 5, Synthes sent a letter to healthcare facilities asking them to stop using HBP if they had it in the identified part and lot numbers. The FDA first posted a notice of the recall on its Web site August 16.

Healthcare facilities that possess the recalled HBP can call Synthes at 1-800-479-6329 for information on how to return the product.

Johnson & Johnson acquired Synthes earlier this year and combined it with its DePuy orthopaedics unit to form DePuy Synthes.

More information on today's announcement is available on the FDA Web site.

To report adverse effects with Synthes HBP, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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