Z-0712-2017Class II

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only

Name: Z-0712-2017 TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only
Creator: DeRoyal Industries Inc
Published: 2016-11-07
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2016-11-07 / Terminated

FDA source

DeRoyal Industries Inc began a recall of TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis on 2016-11-07. FDA classified it as Class II and gives the reason as "DeRoyal received complaints of mold on Tennis Elbow Straps". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0712-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2016-12-06
Terminated: 2022-01-13
Recalling firm: DeRoyal Industries, Inc.
Product: TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Product code: IQI Orthosis, Limb Brace
Reason for recall: DeRoyal received complaints of mold on Tennis Elbow Straps.
FDA root cause: 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
Product codes and lots: Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0712-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0712-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-06
Z-0713-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-06

Product code IQI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)