Z-0544-2014 Class II Terminated
FDA device recall Z-0544-2014 was initiated by SpineFrontier, Inc. on Oct 18, 2013 and is designated Class II. 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… The recall status is terminated (terminated Aug 22, 2016). Affected quantity: 35 Devices.
Recall details
- Product Type
- Devices
- Report Date
- Dec 25, 2013
- Initiation Date
- Oct 18, 2013
- Termination Date
- Aug 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 Devices
Product description
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.
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.
Distribution pattern
US Distribution to VA and TX.
Code information
Lot/Serial Numbers: 357305-000
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0544-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026