SpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty
SpineFrontier, Inc. is recalling Indus Invue Screw Caddies because screws are difficult to remove from the device. The recall affects 13 units distributed in the US and Jamaica.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The specific issue is a functional defect (difficulty removing screws) without reported injuries or fatalities, fitting the Moderate severity criteria for a voluntary precautionary recall of a medical device.
Plain-English summary
SpineFrontier, Inc. is recalling the Indus Invue Screw Caddy, Model SI70097. This medical device is used to hold various shapes and sizes of plates and screws during anterior cervical spine fusion procedures. The recall was initiated because of a difficulty in removing screws from the caddies.
The recall covers 13 units of the product. The affected lot numbers are 7140.014, 6486.008, 10754.011, 6417.005R, 7140.005, 6486.007, and 6486.007R. The recall was expanded on August 21, 2013, to include the additional lots.
The product was distributed worldwide, specifically in the United States (including Connecticut, Virginia, Massachusetts, Florida, Texas, Colorado, and Mississippi) and Jamaica. Users of this device should contact SpineFrontier, Inc. for instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Related recalls
Same manufacturer · SpineFrontier, Inc.
See all →- HighSpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk
FDA (Devices) · 2019-07-24
- ModerateSpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
FDA (Devices) · 2015-04-29
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21
- SevereSpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
FDA (Devices) · 2014-05-14
- ModerateSpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- ModerateSpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
FDA (Devices) · 2014-01-01
- ModerateSpineFrontier Recalls Invue Split Driver Devices Due to Design Flaw
FDA (Devices) · 2013-08-14
- HighSpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments
FDA (Devices) · 2013-08-07
- SevereSpineFrontier Invue Solid Driver Recalled Due to Broken Nipple
FDA (Devices) · 2013-08-21
- ModerateSpineFrontier Recalls Surgical Case Lids and Bases Due to Ink Delamination
FDA (Devices) · 2013-08-21
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21