Reported Jan 2, 2013 · Terminated
Zimmer Spine Ardis Inserter, Rx, non-sterile
Zimmer, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Zimmer Spine Ardis Inserter, Rx, non-sterile
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published — Lot: 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, 75LE Part, 07.00780.701 07.00780.702lot 76CN 07.00900.701lot 76CP — 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 - Amount recalled
- 315 (172 in USA)
Where it was sold
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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