Flexgard, off-the-shelf knee brace, product number 14761106
This recall has been terminated (originally issued March 19, 2003).
- Company
- De Royal Industries
- Recall Initiated
- February 14, 2003
- Posted
- March 19, 2003
- Terminated
- August 22, 2003
- Recall Number
- Z-0658-03
- Quantity
- 13
- Firm Location
- San Luis Obispo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
Distribution
ID, CA, NC, TX, SC, NM, GA and TN
Lot / Code Info
Product number 14761106, Lot numbers: 53078 and 53985
Root Cause
Other
Action Taken
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.