FDA-Device2013-12-25Class II
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.
SpineFrontier, Inc.
Hazard
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.
Sold states
US Distribution to VA and TX.
Affected count
35 Devices
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0544-2014Don't want to check this manually?
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