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U.S. Department of Health and Human Services

Class 1 Device Recall Ardis Interbody System Inserter

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 Class 1 Recall
Ardis Interbody System Inserter
see related information
Date Posted December 22, 2012
Recall Status1 Terminated on February 25, 2014
Recall Number Z-0594-2013
Recall Event ID 63683
Premarket Notification
510(K) Number
K073202 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
Product Zimmer Spine Ardis Inserter, Rx, non-sterile
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;
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact David J. Kunz
952-832-5000
Manufacturer 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
FDA Determined
Cause 2
DESIGN: 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 qualitycompliance@zimmer.com.
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = ABBOTT SPINE, INC.
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