| 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 |
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| 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 |
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| 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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