Recall Z-1933-2013— SpineFrontier, Inc.
Class II · Terminated
Class II FDA medical device recall by SpineFrontier, Inc., initiated 2013-06-21, terminated 2016-01-11. It names one FDA 510(k) clearance: K121060. 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..
- Recalling firm
- SpineFrontier, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-21
- Terminated
- 2016-01-11
- Firm location
- Beverly, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.