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U.S. Department of Health and Human Services

Class 2 Device Recall Zyston Transform TLIF System

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 Class 2 Device Recall Zyston Transform TLIF Systemsee related information
Date Initiated by FirmJune 30, 2016
Create DateAugust 11, 2016
Recall Status1 Terminated 3 on March 15, 2017
Recall NumberZ-2397-2016
Recall Event ID 74687
510(K)NumberK153695 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductZyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Code Information Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.
Recalling Firm/
Manufacturer		 Zimmer Biomet Spine, Inc
310 Interlocken Pkwy
Suite 120
Broomfield CO 80021-3479
For Additional Information ContactAshley McPherson
303-443-7500
Manufacturer Reason
for Recall		Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
FDA Determined
Cause 2		Under Investigation by firm
ActionVerbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email notifications will also be sent to each recall notification addressee before distributing the recall documentation via Federal Express.
Quantity in Commerce5
DistributionNationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
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
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