Zimmer Spine Issues Urgent WW Recall of Interbody Spacer Instrument

ARDIS 2Zimmer Spine Issues Urgent Worldwide Medical Device Recall of the Inserter Instrument for the PEEK Ardis® Interbody Spacer (press release)

MINNEAPOLIS, MN) December 20, 2012—Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter. 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. Intra-operative complaint reports received to date indicate an occurrence rate of 0.52%. Observed health risks associated with implant fragments may include dural tears and blood loss. No post-operative complaints have been reported that are attributed to a fractured implant. Patients with concern about their implant should contact their healthcare provider.

Surgeons and hospitals with PEEK Ardis Inserter instruments should immediately stop using the inserters and return them to Zimmer Spine. Surgery using the PEEK Ardis Interbody Spacer cannot be performed as intended without the aid of the PEEK Ardis Inserter instrument.

This recall includes all lots of the following part numbers that were distributed from June 2008 through December 2012:

 

Part Numbers Lot Numbers Part Numbers Lot Numbers
3256-01 52ZW 07.00780.701
07.00780.702
76CN
76CP
50CL 07.00900.701
07.00900.702
76TR
76TS
53BB 650-0297-01 70YT
55AB 07.00780.701
07.00780.702
73EC
73EC
58GS 07.00900.701 76TQ
58GT 650-0239-01 66PR
60JY 650-0293-01 70SG
60JZ 650-0293-01 70SG-R
62KP 650-0179-01 60CK
63HJ 650-0176-01 60CL
64EY 650-0365-01 72LP
68AX 07.00780.701
07.00780.702
76CQ
76CR
71JE 07.00780.701
07.00780.702
74EN
74EP
75LE 650-0351-01
650-0351-02
72JH
72JJ
650-0263-01 68HL
650-0208-01 62FH
07.00900.701 76TN
07.00780.701 76QG
07.00780.701
07.00780.702
76LC
76LD

Products can be identified by the part number and lot number physically marked on the surgical instrument. Products were distributed nationwide in the United States and around the world. Zimmer Spine has notified the FDA of this action and is working with other regulatory agencies worldwide.

Zimmer Spine is notifying its distributors and customers worldwide via a letter and is arranging for the return of all PEEK Ardis Inserters.

Healthcare professionals or customers may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between the hours of 8AM and 5PM CST or by email at qualitycompliance@zimmer.com.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

CONTACTS:

Zimmer Spine, Inc.
7375 Bush Lake Road
Minneapolis, MN 55439

Media
Garry R. Clark
+1574-372-4493
garry.clark@zimmer.com

Investors
Robert J. Marshall Jr.
+1574-371-8042
robert.marshall@zimmer.com

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