Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Int
FDA device recall Z-0262-2010 · posted 2009-11-13 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc
- Reason for recall
- ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal.
- Action taken
- Firm notified consignees by letter sent via certified mail on 10/9/2009. Follow up is planned for nonresponders. Questions are directed to the firm at (800) 527-0404.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 539 units
- Distribution
- Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.
- Date initiated
- 2009-10-09
- Date posted
- 2009-11-13
- Date terminated
- 2010-09-24
- Location
- McKinney, TX
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