Z-1933-2013 Class II Terminated
FDA device recall Z-1933-2013 was initiated by SpineFrontier, Inc. on Jun 21, 2013 and is designated Class II. Reason for recall: Difficulty removing screws from the Invue caddies. The recall status is terminated (terminated Jan 11, 2016). Affected quantity: 13.
Recall details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Jun 21, 2013
- Termination Date
- Jan 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
Product description
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.
Distribution pattern
Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1933-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026