Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PAK NEEDLE BEVELED AND TROCAR TIPS

  • 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 2 Device Recall PAK NEEDLE BEVELED AND TROCAR TIPSsee related information
Date Initiated by FirmApril 13, 2017
Create DateMay 05, 2017
Recall Status1 Terminated 3 on December 28, 2017
Recall NumberZ-2047-2017
Recall Event ID 77049
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductMedtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Code Information Lot number 0521148W, Exp. 10/21/2021
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information ContactEric Epperson
901-344-1435
Manufacturer Reason
for Recall		Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedtronic sent an Urgent : Field Safety Corrective Action dated April 13, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com, or fax to 763-367-8134. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact our Post-Market Quality team at 901-399-3197. For further questions, please call (901) 344-1435.
Quantity in Commerce36 units
DistributionUS Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
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.
-
-