Date Initiated by Firm |
November 07, 2016 |
Create Date |
December 06, 2016 |
Recall Status1 |
Terminated 3 on January 13, 2022 |
Recall Number |
Z-0713-2017 |
Recall Event ID |
75665 |
Product Classification |
Orthosis, limb brace - Product Code IQI
|
Product |
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,
Product Usage: Lateral and medial epicondylitis
|
Code Information |
Lots: 47001, 49894, and 51311 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
|
For Additional Information Contact |
Brian DeBusk 865-362-1284
|
Manufacturer Reason for Recall |
DeRoyal received complaints of mold on Tennis Elbow Straps.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
DeRoyal issued their recall on 11/7/16 to the physician / clinician level by sending recall letters to its direct accounts and sales representatives. The foreign customer was notified by email on 11/7/2016. The customers were asked to identify the affected products, destroy them and return the provided notice of destruction form to DeRoyal for credit. |
Quantity in Commerce |
791 units |
Distribution |
US Nationwide Distribution |
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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