Recall Z-0544-2014
SpineFrontier, Inc. · initiated October 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Codes / lots: Lot/Serial Numbers: 357305-000
Reason for recall
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
FDA-determined cause: Software design (manufacturing process)
Action taken
SpineFrontier sent an Voluntary Recall Notification dated November 5,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. All affected implants are to be returned to SpineFrontier for inspection. SpineFrontier is requiring confirmation that you have received this notice and that you will initiate the immediate return of the implants listed above. IMMEDIATE RESPONSE REQUIRED. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions
Details
- Recall number
- Z-0544-2014
- Initiated
- October 18, 2013
- Posted by FDA
- December 19, 2013
- Terminated
- August 22, 2016
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Quantity
- 35 Devices
- Distribution
- US Distribution to VA and TX.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA