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Class 2 Device Recall Dart Fire HEADED SCREW 4.0X 32MM |
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| Date Initiated by Firm |
November 08, 2016 |
| Create Date |
November 25, 2019 |
| Recall Status1 |
Terminated 3 on November 03, 2020 |
| Recall Number |
Z-0567-2020 |
| Recall Event ID |
84180 |
| Product Classification |
Screw, fixation, bone - Product Code HWC
|
| Product |
Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S |
| Code Information |
Lot Number 1555125 |
Recalling Firm/
Manufacturer |
Wright Medical Technology, Inc.
11576 Memphis Arlington Rd
Arlington TN 38002-9497
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Manufacturer Reason
for Recall |
The firm discovered a lack of adequate documentation confirming sterility on certain products.
|
FDA Determined
Cause 2 |
Process control |
| Action |
The 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 Commerce |
77 units |
| Distribution |
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain |
| Total Product Life Cycle |
TPLC Device Report
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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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