Indus Invue Screw Caddy — Class II medical device recall Z-1933-2013
Terminated recall by SpineFrontier, Inc., reported 2013-08-14, distributed in CO, CT, FL, MA, MS, TX, VA. Difficulty removing screws from the Invue caddies.
| Recall number | Z-1933-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-06-21 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2016-01-11 |
| Distributed | CO, CT, FL, MA, MS, TX, VA |
| Countries outside the US | JM |
| Quantity | 13 |
| Lot numbers | 10754.011, 6417.005R, 6486.007, 6486.007R, 6486.008, 7140.005, 7140.014 |
| Model numbers | SI70097 |
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 for recall
Difficulty removing screws from the Invue caddies.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1933-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.