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U.S. Department of Health and Human Services

Class 2 Device Recall Indus Invue Screw Caddy

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 Class 2 Recall
Indus Invue Screw Caddy
see related information
Date Posted August 08, 2013
Recall Status1 Open
Recall Number Z-1933-2013
Recall Event ID 65653
Premarket Notification
510(K) Number
K121060 
Product Classification Tray, Surgical, Instrument - Product Code FSM
Product Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.
Code Information Lot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
For Additional Information Contact Helen Moon
978-232-3990
Manufacturer Reason
for Recall
Difficulty removing screws from the Invue caddies.
FDA Determined
Cause 2
DESIGN: Device Design
Action SpineFrontier sent a Urgent Invue Caddy Advisory letter dated July 10, 2013, to all affected customers. Customers were advised the removal of the Invue Screw Caddy, SI70097 from the field for modification. Customers were asked to return the parts to SpineFrontier and to complete an Acknowledgement Form indicating that they have read the notice and will initiate the immediate return of the parts noted above. Please feel free to contact us at (978) 232-3990. On 8/21/2013 the recall was expanded.
Quantity in Commerce 13
Distribution Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FSM and Original Applicant = SPINEFRONTIER, INC.
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