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DEVICE SPLITS IN HALF DURING SURGERY; WARNING LETTER FOLLOWS

Feb. 23, 2007

Encore Medical's reworking of its Speedblock surgical instruments caused the premature failure and splitting in half of the devices during surgery, prompting a recall of the product, the FDA said in a recent warning letter.

The firm's contract manufacturer delivered Speedblocks that did not meet Encore's approved specifications, and the company decided to rework the devices in house, according to the letter, posted to the FDA website Jan. 30.

A complaint from March 2006 showed that reworking led to violations. But the firm did not evaluate and document any adverse effect of its reworking of the product, the letter said.

Inspections from Sept. 30 to Oct. 11, 2006, found Encore's products to be adulterated because the firm was in violation of current good manufacturing practice requirements. In addition, the devices were misbranded because the firm failed to provide material or information required under the medical device reporting regulation. Encore also failed to adequately review, evaluate and investigate complaints regarding the possible failure of a device.

The warning letter can be seen at www.fda.gov/foi/warning_letters/g6209d.htm ( http://www.fda.gov/foi/warning_letters/g6209d.htm ).

( http://www.fdanews.com/ddl/34_8/ )