NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
Reported: October 14, 2020 Initiated: July 24, 2020 #Z-0069-2021
Product Description
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
Reason for Recall
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Details
- Recalling Firm
- Nuvasive Specialized Orthopedics Inc
- Units Affected
- 41 total units
- Distribution
- Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands.
- Location
- Aliso Viejo, CA
Frequently Asked Questions
What product was recalled? ▼
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).. Recalled by Nuvasive Specialized Orthopedics Inc. Units affected: 41 total units.
Why was this product recalled? ▼
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0069-2021.
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