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Class 2 Device Recall Flexgard, offtheshelf knee brace |
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| Date Initiated by Firm |
February 14, 2003 |
| Date Posted |
March 19, 2003 |
| Recall Status1 |
Terminated 3 on August 22, 2003 |
| Recall Number |
Z-0658-03 |
| Recall Event ID |
25659 |
| Product Classification |
Joint, Knee, External Brace - Product Code ITQ
|
| Product |
Flexgard, off-the-shelf knee brace, product number 14761106 |
| Code Information |
Product number 14761106, Lot numbers: 53078 and 53985 |
Recalling Firm/
Manufacturer |
De Royal Industries
870 Industrial Way
San Luis Obispo CA 93401
|
| For Additional Information Contact |
Mr. Tracy Edmundson
865-938-7828
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Manufacturer Reason
for Recall |
Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
|
FDA Determined
Cause 2 |
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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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