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Zimmer Issues Recall, Suspends Production at Ohio Plant

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Orthopedic Surgical Products (OSP) manufactured by Zimmer Holdings have been recalled, and production at the plant that produced them has been suspended after a recent inspection uncovered quality problems at the facility. 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.

The Zimmer OSP division in Dover, Ohio 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. 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 Food & Drug Administration (FDA), distributors and end-users of the recalls.

Though the company press release did not list the products included in the recall, according to the 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.

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