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At a glance
Zimmer Holdings Inc. has recalled the Ardis (PEEK) Inserter, which is used during spinal fusion surgery to reduce back pain caused by degeneration of a disc.
The Food and Drug Administration has designated the recall a Class I, meaning patients could suffer severe injury or death.
The instrument is used during surgery to implant the Ardis PEEK Interbody Spacer, which can break if the surgeon applies excessive pressure to the Ardis Inserter.

Recall offers vital lessons

Responsibility, concern regarded as smartest response


It’s a problem no company wants to deal with.

Zimmer Holdings Inc. in late December recalled its Ardis (PEEK) Inserter, an instrument used during spinal surgery.

It’s not the first recall by one of Warsaw’s Big Three orthopedic devices manufacturers – DePuy Orthopaedics recalled its ASR artificial hip implants in 2010, for example. And it probably won’t be the last orthopedic-industry recall issued.But it provides an opportunity to look at how manufacturers can handle crisis situations.

Public relations experts say companies should prepare for such events. Having a plan allows them to respond quickly while keeping everyone on the same page.

Kevin Erb, Ferguson Advertising’s public relations and social media director, compares pulling out a crisis management plan to breaking the glass over a fire extinguisher.

Having a detailed plan keeps companies from serious missteps, such as trying to duck issues instead of facing them head-on, he said.

Erb believes officials’ response sets the tone for media coverage and public reaction.

“It’s not the crime, it’s the cover-up,” he said.

Logan Jordan, associate dean at Purdue University’s Krannert School of Management in West Lafayette, said product recalls are part of life. So companies should use those situations as opportunities to talk about their safety protocols.

“The first thing is what you did to anticipate or prevent it,” he said. “And the second thing is what you did in response.”

When the product is a medical device, it’s important to help the public visualize the product’s benefits vs. costs and risks, Jordan said.

The 1982 Tylenol case is often referred to as the model for the right way to handle a product recall. Johnson & Johnson pulled the product off store shelves nationwide after reports of patient deaths in Chicago.

J&J, which owns DePuy, reintroduced Tylenol with tamper-resistant packaging that has become standard for over-the-counter medicine.

Throughout the crisis, J&J took responsibility and expressed concern about public safety, said Kent Kauffman, assistant professor of business law at IPFW. Doing so, he said, didn’t require the company to admit fault.

Tom Borne, Asher Agency’s president, pointed to Toyota as an example that companies shouldn’t follow.

When problems arose with the Japanese company’s vehicles, officials avoided responsibility. They blamed floor mats for making accelerators stick. Months of negative PR followed.

“They used what I call the ‘drip-drip-drip method,’ ” he said.

Borne said officials should first consult an attorney and then communicate a quick and truthful message.

“You just can’t dodge the issue.”