| Class 2 Device Recall Indus Invue Screw Caddy | |
Date Initiated by Firm | June 21, 2013 |
Date Posted | August 08, 2013 |
Recall Status1 |
Terminated 3 on January 11, 2016 |
Recall Number | Z-1933-2013 |
Recall Event ID |
65653 |
510(K)Number | K121060 |
Product Classification |
Tray, surgical, instrument - Product Code FSM
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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 MA 01915-6516
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For Additional Information Contact | Helen Moon 978-232-3990 |
Manufacturer Reason for Recall | Difficulty removing screws from the Invue caddies. |
FDA Determined Cause 2 | 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 |
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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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510(K) Database | 510(K)s with Product Code = FSM
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