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U.S. Department of Health and Human Services

Class 2 Device Recall TENNIS ELBOW SUPPORT

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  Class 2 Device Recall TENNIS ELBOW SUPPORT see related information
Date Initiated by Firm November 07, 2016
Create Date December 06, 2016
Recall Status1 Terminated 3 on January 13, 2022
Recall Number Z-0712-2017
Recall Event ID 75665
Product Classification Orthosis, limb brace - Product Code IQI
Product TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only,

Product Usage:
Lateral and medial epicondylitis
Code Information Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441
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 56 units
Distribution US Nationwide Distribution
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.
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