Z-0658-03

Flexgard, off-the-shelf knee brace, product number 14761106

Name: Z-0658-03 Flexgard, off-the-shelf knee brace, product number 14761106
Creator: De Royal Industries
Published: 2003-02-14
License: https://open.fda.gov/license/

De Royal Industries / initiated 2003-02-14 / Terminated / root cause: manufacturing process

FDA source

De Royal Industries began a recall of Flexgard, off-the-shelf knee brace, product number 14761106 on 2003-02-14. The reason FDA records is "Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0658-03
Status: Terminated
Initiated: 2003-02-14
Posted: 2003-03-19
Terminated: 2003-08-22
Recalling firm: De Royal Industries
Product: Flexgard, off-the-shelf knee brace, product number 14761106
Product code: ITQ Joint, Knee, External Brace
Reason for recall: Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 13
Distribution: ID, CA, NC, TX, SC, NM, GA and TN
Product codes and lots: Product number 14761106, Lot numbers: 53078 and 53985

Product code ITQ

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)