Recall of Stryker Rejuvenate,

Recall of Stryker Rejuvenate,

Stryker Hip Recall

On July 6, 2012, the Stryker Corporation, one of the world’s largest manufacturers of medical equipment and orthopaedic devices, recalled two of its artificial hip implant systems — the Rejuvenate Modular and ABG II Modular-Neck Hip Stems. The company stopped all global sales and production of these components.

Stryker Rejuvenate and ABG II Recalled

The recall came three months after Stryker issued an “Urgent Field Safety Notice” to implant surgeons and hospital risk managers pointing out the potential health hazards associated with the two products — including corrosion and “fretting,” which allows minute shards of its metallic components to leach into a patient’s tissues, bones and/or bloodstream.

Another hip stem, the Accolade TMZF, also caused problems. The company recalled those models in 2009, 2011 and 2013 because of packaging and manufacturing errors. This hip is made of the same proprietary titanium alloy as the Rejuvenate and ABG II and may corrode and fret when used with cobalt chromium femoral heads. It causes many of the same problems as the other two stems.

After a number of people suffered painful side effects like tissue and bone death at the implant site and early device failure, Stryker is now faced with mounting lawsuits filed by plaintiffs and their families.

Why Stryker Recalled Rejuvenate, ABG II and Accolade

Stryker’s official recall announcement, dated July 6, 2012, stated that the company’s decision to “remove Rejuvenate and ABG II stems and terminate global distribution of these products comes after continued post-market surveillance.” The company’s vice president and general manager of hip reconstruction, Stuart Simpson, added: “Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data.”

The neck components of the Rejuvenate and ABG II are made of chromium and cobalt, and the stems are coated with titanium. When these parts wear against each other where the neck meets the stem, they can shed metallic debris into the body and lead to complications.

In an Urgent Field Safety Notice issued immediately before the recall, Stryker warned that post-market data revealed that the Rejuvenate and ABG II had an increased rate in Adverse Local Tissue Reaction (ALTR) – meaning complications arising from inflammation in the tissue in and around the implant.

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