Z-0594-2013 Class I Terminated
FDA device recall Z-0594-2013 was initiated by Zimmer, Inc. on Nov 12, 2012 and is designated Class I. 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… The recall status is terminated (terminated Feb 25, 2014). Affected quantity: 315 (172 in USA).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2013
- Initiation Date
- Nov 12, 2012
- Termination Date
- Feb 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315 (172 in USA)
Product Description
Zimmer Spine Ardis Inserter, Rx, non-sterile
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
Distribution Pattern
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.
Code Information
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;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0594-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026