Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or low
FDA device recall Z-1665-2015 · posted 2015-05-23 · Terminated
Recall details
- Recalling firm
- United Surgical Associates
- Reason for recall
- The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
- Action taken
- On 4/13/2015 United Ortho emailed the affected distributor regarding the need for correction due to latex in the product and that updated labeling and instructions would be provided. United-Ortho personnel will travel to Hawaii and accompany the distributor to label the product at the sites to which it was distributed. Records will be maintained at each location.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- ITQ
- Quantity affected
- 1260
- Distribution
- Domestic: HI International; None
- Date initiated
- 2015-04-13
- Date posted
- 2015-05-23
- Date terminated
- 2015-07-14
- Location
- Fort Wayne, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.