Zimmer Holdings has initiated a recall of certain Orthopedic Surgical Products (OSP) produced at its manufacturing plant in Dover, Ohio.  Zimmer has also announced that it has suspended production at the Dover, Ohio plant and ceased sales of some of the OSP products produced there because a recent review of the facility revealed that quality systems were not up to standards.

“There are no patient safety issues, and this recall does not impact Zimmer’s core hip and knee franchise,” Bob Hopkins of New York-based Lehman Brothers said in a research note. “The recall is due entirely to issues with the packaging of certain products related to surgical wound cleansing.”

The Zimmer press release announcing the recall said the company had recently conducted a review of quality systems at the Dover, Ohio OSP facility and determined that some products did not meet internal quality standards. Zimmer decided to suspend production there in order to focus on the needed improvements to manufacturing and conduct enhanced quality training for employees.  Zimmer said it had has notified the FDA, distributors and end-users of the recalls.

The Zimmer OSP division produces a variety of patient care items used to
support orthopedic surgery, including disposables used in blood
management, surgical wound site debridement and cement accessories. Though the company press release did not list the products included in the recall, according to the Food & Drug Administration (FDA) website, the following Zimmer OSP products produced at the Ohio plant were subject to recall late last year:

• Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package
• Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package
• Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package
• Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package
• Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package
• Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package
• Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package
• Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package
• Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package

All of these Zimmer OSP recalls were initiated in December 2007, but were not posted to the FDA website until March 6, 2008. Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008, and requested that customers inventory their stock. If any recalled product was located, the customer was to notify Zimmer via fax and a replacement part would be shipped to them. The reason given for the recalls was that sterility of the products had been compromised.

Zimmer said that these actions are expected to adversely impact 2008 OSP revenues by $70 to $80 million.  The past year has been a tough one for Zimmer holdings, which last September was one of several orthopedic device makers that agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services as part of a probe into illegal kickbacks paid to doctors by orthopedic device makers.

This entry was posted on Monday, April 7th, 2008 at 6:39 am and is filed under Legal News, Defective Medical Devices.