Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is
FDA device recall Z-3127-2017 · posted 2017-08-18 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc
- Reason for recall
- The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
- Action taken
- Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 6 planers
- Distribution
- Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
- Date initiated
- 2017-08-02
- Date posted
- 2017-08-18
- Date terminated
- 2018-05-04
- Location
- Lewisville, TX
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