Zimmer Spine issues worldwide recall of interbody spacer inserter

Zimmer Spine Inc. initiated a voluntary worldwide recall of the PEEK Ardis Inserter, a surgical instrument used to implant the PEEK Ardis Interbody Spacer, according to a press release dated December 20, 2012.The inserters are being recalled because Zimmer Spine received reports of the Ardis implant breaking when it is subjected to “excessive lateral and/or off-axis forces from the inserter during surgery,” according to a company press release.Based on the complaint reports that Zimmer Spine has received to date, there is a 0.52% rate of intraoperative implant breakage.Zimmer Spine stated in the release that implant fragments may pose such health risks as dural tears and blood loss; however there have been no postoperative complaints due to a fractured implant.Patients concerned about their implant should contact their healthcare provider.A Zimmer representative told Orthopedics Today that hospitals are being notified directly with more clinical information.Surgeons and hospitals currently using the inserters should discontinue use and immediately return them to Zimmer Spine. The interbody spacer cannot be implanted as intended without using the inserter, according to the press release, as well as recall letter dated today that was sent to surgeons and hospitals.The Ardis Interbody System was released for commercial use in 2008. The recall affects 315 inserter instruments worldwide, including 122 inserters distributed in the United States and 143 inserters distributed internationally. The recall also applies to 50 specialty Ardis Inserters released in the United States, according to the recall letter.