Recall StatusTerminated
Date Initiated2012-08-06
Date Terminated2013-05-17
Product Quantity1224
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.