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U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Biomet Spine

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  Class 3 Device Recall Zimmer Biomet Spine see related information
Date Initiated by Firm July 07, 2016
Create Date May 10, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1892-2017
Recall Event ID 76652
510(K)Number K113561  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
Code Information n/a
Recalling Firm/
Manufacturer		 Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact Mr. Kevin Escapule
973-576-0032
Manufacturer Reason
for Recall		 This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Zimmer Biomet sent an Urgent Medical Device Correction Notice dated July 7, 2016, to all consignees on the list requiring them to destroy all literature and notify Zimmer Biomet of others who they have disseminated the material further. Retraining the sales force on the use of the TM Ardis. The details of the strategy are contained within the Draft Recall Strategy attached to the email transmitting this report. For further questions, please call (973) 576-0032.
Quantity in Commerce 299 units; 200 brochures
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = ZIMMER TRABECULAR METAL TECHNOLOGY
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