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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MAX
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