FDA Device recall Z-1933-2013
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates a…
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates a… by Spinefrontier, citing difficulty removing screws from the Invue caddies.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1933-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-21 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | CO, CT, FL, MA, MS, TX, VA |
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.
Reason
Difficulty removing screws from the Invue caddies.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1933-2013%22
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