FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
- Recall number
- Z-0713-2017
- Recalling firm
- DeRoyal Industries Inc
- Product
- PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
- Status
- Terminated
- Initiated
- 2016-11-07
- Posted
- not on file
- Terminated
- 2022-01-13
- Reason
- DeRoyal received complaints of mold on Tennis Elbow Straps.
- 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
- 791 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lots: 47001, 49894, and 51311
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQI
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28