The Food and Drug Administration said more than 300 spinal surgical instruments recalled last week by Zimmer Holdings Inc. could potentially cause serious injury or death.
Warsaw-based Zimmer announced Dec. 20 it was recalling 315 Peek Ardis Inserters after reports that the devices could cause surgical delays and injury when used with in spinal surgery.
Zimmer said too much force on the tool could cause another implant to break during surgery, potentially damaging the cover of the spinal cord, or causing blood loss or nerve injury.
FDA issued a statement Friday saying it classified the company’s action as a Class I recall, meaning patients treated with the devices could be seriously injured or die.
The agency notes that the recalled device is an essential part of Zimmer’s Peek Ardis Implant System, which will be unavailable for use until a redesigned inserter is cleared by the FDA.
Tribune emerges from bankruptcy
Tribune Co., owner of the Chicago Tribune, Los Angeles Times and six other daily papers, has emerged from bankruptcy, four years after a doomed leveraged buyout by billionaire Sam Zell led to Chapter 11 proceedings.
Distributions to creditors have been initiated, the Chicago-based company said Monday in a statement.
As part of its exit from bankruptcy, Tribune Co. also closed on a new $1.1 billion term loan and a $300 million revolving credit line.
The company is now in a position to begin a wide-ranging sale of assets including stakes in the Food Network and CareerBuilder Inc., newspapers including the Times and the Tribune as well as real estate, Lance Vitanza, managing director at CRT Capital Group, said in a interview.
In addition to eight daily newspapers, Tribune Co. owns 23 TV stations and stakes in more than 50 websites.
Ford predicts sales totaling 2.2 million
Ford said it expected to sell 2.2 million vehicles for 2012, with the Ford Focus compact car being its most popular model.
The Dearborn, Mich., company said it would be the second year in a row it will sell more than 2 million cars. It sold 737,856 Ford Focuses through September.
The Ford Fiesta sedan and hatchback and F-series trucks were other popular models, with Ford selling 560,061 Fiestas and 576,339 F-Series vehicles through September.
Ford Motor Co.’s EcoBoost engines, which save energy, were on track to be sold in 520,000 cars by year-end since their launch in 2009.
A new 1-liter, 3-cylinder engine will be available in 2013 in new Fiesta cars in the U.S.
Kansas firm to buy Ann Arbor Railroad
A Kansas company says it has a deal to buy the short line Michigan rail company Ann Arbor Railroad Inc.
Pittsburg, Kan.-based Watco Cos. LLC says the deal awaits approval from the Surface Transportation Board, which is expected in late January or early February.
The Ann Arbor Railroad serves southeast Michigan and the Toledo area, mainly shipping auto and other manufacturing goods.
The railroad operates 50 miles of track between Ann Arbor and Toledo and has Toledo-area terminals serving General Motors Co., Chrysler and Ford Motor Co.