FDA Medical Device Recalls (openFDA)
De Royal Industries: Flexgard, off-the-shelf knee brace, product number 14761106
- Recall number
- Z-0658-03
- Recalling firm
- De Royal Industries
- Product
- Flexgard, off-the-shelf knee brace, product number 14761106
- Status
- Terminated
- Initiated
- 2003-02-14
- Posted
- 2003-03-19
- Terminated
- 2003-08-22
- Reason
- Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
- Root cause
- Other
- Action
- The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees if the product was further distributed.
- Quantity
- 13
- Distribution
- ID, CA, NC, TX, SC, NM, GA and TN
- Lot, serial or model codes
- Product number 14761106, Lot numbers: 53078 and 53985
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITQ
- Firm FEI
- 2021791
- Firm city
- San Luis Obispo
- Firm state
- CA
- 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