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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Shoulder Retractors

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  Class 2 Device Recall CIVCO Shoulder Retractors see related information
Date Initiated by Firm August 19, 2015
Date Posted September 14, 2015
Recall Status1 Terminated 3 on October 07, 2016
Recall Number Z-2763-2015
Recall Event ID 71935
Product Classification Restraint, protective - Product Code FMQ
Product CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX.
For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
Code Information Lot numbers M765570 and M784310.
Recalling Firm/
Med Tec Inc
1401 8th St SE
PO Box 320
Orange City IA 51041-7463
For Additional Information Contact James Leong
Manufacturer Reason
for Recall
The wrist straps used for positioning the patient are too long
FDA Determined
Cause 2
Vendor change control
Action Med Tec Inc sent an Urgent Field Correction Notice dated August 18, 2015, via e-mail on August 19, 2015, and made phone calls on August 19, 2015, to all affected customers requesting return of the product. Customers were instructed to forward a copy of the notification letter to all customers who have received the product. Customers with questions were instructed to reach their representative by calling CIVCO Medical Solutions, adiation Oncology, at 800-842-8688 or 319-248-8688 between 8:00AM and 5:00PM CST. For questions regarding this recall call319-248-6502.
Quantity in Commerce 18 sets
Distribution Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong
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.