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U.S. Department of Health and Human Services

Class 2 Device Recall Dart Fire HEADED SCREW 4.0X 32MM

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 Class 2 Device Recall Dart Fire HEADED SCREW 4.0X 32MMsee related information
Date Initiated by FirmNovember 08, 2016
Create DateNovember 25, 2019
Recall Status1 Terminated 3 on November 03, 2020
Recall NumberZ-0567-2020
Recall Event ID 84180
Product Classification Screw, fixation, bone - Product Code HWC
ProductDart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
Code Information Lot Number 1555125
FEI Number 1043534
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
11576 Memphis Arlington Rd
Arlington TN 38002-9497
Manufacturer Reason
for Recall		The firm discovered a lack of adequate documentation confirming sterility on certain products.
FDA Determined
Cause 2		Process control
ActionThe firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
Quantity in Commerce77 units
DistributionUS and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
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.
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