Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthen

FDA device recall Z-0895-2013 · posted 2013-02-28 · Terminated

Recall details

Recalling firm

Orthofix, Inc

Reason for recall

There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.

Action taken

Orthofix sent an Urgent Product Recall Notification letter dated August 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue distribution of devices, identify the affected and remove from their inventory, and returned to the firm. Credit will be issued upon receipt of the returned product. Customers were asked to take the actions listed in the enclosed Product Return Instructions immediately. Customers with questions should contact Orthofix Customers Service by telephone at 800-266-3349 or 214-937-2047. For questions regarding this recall call 214-937-2509.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HSB

Quantity affected

1224

Distribution

Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, J

Date initiated

2012-08-06

Date posted

2013-02-28

Date terminated

2013-05-17

Location

Lewisville, TX

Related 510(k) clearances