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.
FDA Recall Z-1933-2013 · Posted 2013-08-08
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Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeFSM
Date Initiated2013-06-21
Date Terminated2016-01-11
Product Quantity13
Reason for Recall
Difficulty removing screws from the Invue caddies.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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