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U.S. Department of Health and Human Services

Class 2 Device Recall Fenestrated Tap Adapter

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  Class 2 Device Recall Fenestrated Tap Adapter see related information
Date Initiated by Firm April 18, 2019
Create Date May 25, 2019
Recall Status1 Terminated 3 on June 19, 2020
Recall Number Z-1492-2019
Recall Event ID 82716
510(K)Number K152872  
Product Classification Instrument, biopsy - Product Code KNW
Product Fenestrated Tap Adapter (REF# 5001-90011)

Product Usage:
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Code Information All lots in distribution
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
For Additional Information Contact Meriam Gabera
201-749-8043
Manufacturer Reason
for Recall		 The products are mislabeled.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall notification letters dated 4/18/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact the Regulatory Compliance Team: Spine-RegulatoryActions@Stryker.com or 201.749.8090.
Quantity in Commerce 462 total
Distribution The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
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 = KNW and Original Applicant = K2M
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