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U.S. Department of Health and Human Services

Class 2 Device Recall Radiolucent Spine Surgery Frame

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  Class 2 Device Recall Radiolucent Spine Surgery Frame see related information
Date Initiated by Firm October 06, 2017
Create Date February 20, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-0642-2018
Recall Event ID 79205
Product Classification Table, surgical with orthopedic accessories, manual - Product Code JEB
Product Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Code Information Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200 
Recalling Firm/
Manufacturer		 Allen Medical Systems
100 Discovery Way
Acton MA 01720-4481
Manufacturer Reason
for Recall		 The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
FDA Determined
Cause 2		 Device Design
Action In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30  5:00 pm EST.
Quantity in Commerce 161 units total
Distribution Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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