Z-0594-2013Class I

Zimmer Spine Ardis Inserter, Rx, non-sterile

Name: Z-0594-2013 Zimmer Spine Ardis Inserter, Rx, non-sterile
Creator: Zimmer, Inc.
Published: 2012-11-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-11-12 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Zimmer Spine Ardis Inserter, Rx, non-sterile on 2012-11-12. FDA classified it as Class I and gives the reason as "Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0594-2013
Classification: Class I
Status: Terminated
Initiated: 2012-11-12
Posted: 2012-12-22
Terminated: 2014-02-25
Recalling firm: Zimmer GmbH
Product: Zimmer Spine Ardis Inserter, Rx, non-sterile
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer Spine, sent a "MEDICAL DEVICE CORRECTION" memo dated November 12, 2012 to all consignees / customers describing product, problem and actions to be taken including revised surgical technique. Beginning the week of December 17, 2012, Zimmer began the immediate retrieval of the affected units as a Class I recall. December 20, 2012 nation wide press outlining the recall was issued. 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 [email protected].
Quantity in commerce: 315 (172 in USA)
Distribution: Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.
Product codes and lots: Ardis Inserter, Part number: 3256-01, Lot: 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, 75LE Part, 07.00780.701, lot 76CN; part 07.00780.702, lot 76CP;part 07.00900.701, lot 76TR; 07.00900.702, 76TS; 650-0297-01, 70YT; 07.00780.701, 73EC; 07.00780.702, 73EC; 07.00900.701, 76TQ; 650-0239-01, 66PR; 650-0293-01, 70SG ; 650-0293-01, 70SG-R; 650-0179-01, 60CK; 650-0176-01, 60CL; 650-0365-01, 72LP; 07.00780.701, 76CQ; 07.00780.702, 76CR; 07.00780.701, 74EN; 07.00780.702, 74EP; 650-0351-01, 72JH; 650-0351-02, 72JJ; 650-0263-01, 68HL; 650-0208-01, 62FH; 07.00900.701, 76TN; 07.00780.701, 76QG; 07.00780.701, 76LC; 07.00780.702, 76LD;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0594-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0594-2013	Class I	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-21

Product code MAX

K073202Class IIArdis SpacerAbbott Spine, Inc. / cleared 2008-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)