Zimmer ($ZMH) is recalling all 315 lots of a spinal surgical instrument because of reports that the tool, in some cases, snapped the implant it is designed to handle. The company is afraid the resulting fragments left behind could tear tissue and cause bleeding.
The specific surgical tool under scrutiny here is the company's PEEK Ardis Inserter, which is used to implant the company's PEEK Ardis Interbody Spacer during spinal surgery. There's a lot of caution at play, because the company notes that complaints have bumped the breakage rate up to about 0.52%. But Zimmer, clearly choosing to err on the side of caution, insists that it hasn't yet received any postoperative complaints relating to a fractured implant.
Zimmer's recall affects lots distributed between June 2008 and December 2012, sold in the U.S. and globally, and the company said it is working with FDA officials and other regulatory agencies around the world to coordinate the recall. The company wants surgeons and hospital with PEEK Ardis Inserter surgical tools to stop using them immediately and return them to the company. That, not surprisingly, will prevent the use of the company's PEEK Ardis Interbody Spacer, because it is meant to be implanted only with the Inserter tool.
Zimmer is getting the word to distributors and customers via a letter and lists details of the action at www.peekardis.zimmer.com.
Zimmer's other major regulatory issue this year has involved a hip-replacement device. The company got hit with a warning letter earlier this year regarding manufacturing shortfalls over its Trilogy Acetabular System devices at a facility in Puerto Rico. Zimmer is also part of the cadre of all-metal hip manufacturers that the FDA is scrutinizing over safety concerns for those devices.
- read the recall announcement