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SpineFrontier, Inc. recalls Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes
Recalled August 14, 2013 · FDA recall Z-1933-2013 · SpineFrontier
Hazard
Difficulty removing screws from the Invue caddies. · FDA Class II
Units
13
Sold at
Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
Description
Difficulty removing screws from the Invue caddies.
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.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →