• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Biomet Spine

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Zimmer Biomet Spinesee related information
Date Initiated by FirmJuly 07, 2016
Create DateMay 10, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-1892-2017
Recall Event ID 76652
510(K)NumberK113561 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductThe 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 ContactMr. 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
ActionZimmer 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 Commerce299 units; 200 brochures
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
-
-