Zimmer Spine is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis inserter, according to an FDA news release.
The Ardis inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis interbody spacer.
The inserters are being recalled because Zimmer Spine has received reports of PEEK Ardis interbody spacer implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery.
Surgeons and hospitals with PEEK Ardis inserter instruments should immediately stop using the inserters and return them to Zimmer Spine.
This recall includes all lots of the following part numbers that were distributed from June 2008 through December 2012:
|
Inserter in Ardis Instrument Set |
3256-01 |
|||
|
Specialty Ardis Inserter |
07.00780.701 |
650-0176-01 |
650-0239-01 |
650-0297-01 |
|
07.00780.702 |
650-0179-01 |
650-0263-01 |
650-0351-01 |
|
|
07.00900.701 |
650-0208-01 |
650-0293-01 |
650-0351-02 |
|
|
07.00900.702 |
|
|
650-0365-01 |
|
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