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Terminated

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

FDA Recall Z-0658-03 · Posted 2003-03-19

Recalling FirmDe Royal Industries
Recall StatusTerminated
Product CodeITQ
Date Initiated2003-02-14
Date Terminated2003-08-22
Product Quantity13

Reason for Recall

Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.

Firm 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.

Root Cause

Other

Distribution Pattern

ID, CA, NC, TX, SC, NM, GA and TN

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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