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U.S. Department of Health and Human Services

Class 2 Device Recall Screw Caddy, 8MM adn 9MMPedFuse

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  Class 2 Device Recall Screw Caddy, 8MM adn 9MMPedFuse see related information
Date Initiated by Firm October 05, 2012
Date Posted August 01, 2013
Recall Status1 Terminated 3 on July 29, 2015
Recall Number Z-1869-2013
Recall Event ID 64987
Product Classification Tray, surgical, instrument - Product Code FSM
Product Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B

The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Code Information 31176, 018652, 018645R, 42011
Recalling Firm/
Manufacturer		 SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information Contact Helen Moon
978-232-3990
Manufacturer Reason
for Recall		 Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
FDA Determined
Cause 2		 Device Design
Action The firm, SpineFrontier, sent an Advisory Notice entitled "URGENT May 1, 2013, PedFuse Screw Caddy Removal" dated May 1, 2013 to their consignees/customers. The notice described the product, problem and action to be taken. Consignees/customers were informed that a removal has been initiated to remove the parts from the field to ensure that all sets contain correctly marked screw caddies. Consignees/customers wre instructed to complete and return the URGENT PedFuse Screw Caddy Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email: customerservice@spinefrontier.com. Replacement caddies will be shipped upon receipt of completed acknowledgement form and RMA request for part return. Please feel free to contact SpineFrontier at 978-232-3990 with any questions.
Quantity in Commerce 11 caddies
Distribution US distribution in states of: CO, DC, MA and TX.
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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