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U.S. Department of Health and Human Services

Class 2 Device Recall Allen Bow Frame

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  Class 2 Device Recall Allen Bow 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-0641-2018
Recall Event ID 79205
Product Classification Table, surgical with orthopedic accessories, manual - Product Code JEB
Product Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Code Information Serial Number: A402596 A404960 A407142 A408656 A411816 A415114 A416956 A402597 A404961 A407143 A408657 A411817 A415115 A416957 A402598 A404962 A407144 A408658 A411818 A415116 A416958 A402599 A404963 A407145 A409320 A411819 A415117 A416959 A402604 A404964 A407146 A409321 A411820 A415726 A416960 A402605 A404965 A407460 A409322 A412539 A415727 A416961 A402606 A404966 A407147 A409323 A412540 A415728 A417547 A402607 A405472 A407461 A409335 A412541 A415729 A417548 A402608 A405473 A407885 A409336 A412542 A416163 A417549 A402609 A405474 A407886 A410068 A412543 A416164 A417550 A402610 A405475 A407887 A410069 A412544 A416165 A417919 A402611 A405476 A407888 A410070 A412545 A416166 A543137 A403277 A405477 A407889 A410071 A412546 A416167  A403278 A405478 A407890 A410072 A413529 A416168  A403279 A405479 A407891 A410073 A413530 A416169  A403280 A405787 A407892 A410074 A413531 A416170  A403281 A405788 A407893 A410075 A413532 A416270  
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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