Innovasis Recalls Oryx Cervical Screw Caddies Due to Incorrect Labeling
Innovasis is recalling six Oryx Cervical Screw Caddies because the labels for fixed and variable rescue screws are swapped. This mislabeling could lead to improper screw installation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a labeling error that could lead to improper installation and potential mechanical failure (screw backing out). This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Innovasis, Inc. is recalling six units of the Oryx Cervical Screw Caddy, Model Number BTA-172, which is part of the Oryx Cervical Plate System. The affected units have serial numbers 2339, 2340, 2346, 2351, 2352, and 2354. These devices were distributed nationwide in the United States, including in California, Alabama, and Louisiana.
The recall was initiated because the caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. Specifically, the location labeled "Fixed" should be labeled "Variable," and the location labeled "Variable" should be labeled "Fixed."
If a user installs a fixed rescue screw instead of a variable one due to the mislabeling, the screw head may not sit flush. This could cause the screw to back out, which might interfere with the cover screw. The Oryx Cervical Plate System is intended for use in anterior cervical fixation.
The recalled product
- Product
- Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
- Manufacturer
- Innovasis, Inc
- Affected units
- 6
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)
- Serial numbers: 2339
- 2340
- 2346
- 2351
- 2352
- 2354
Distribution
Related recalls
Same manufacturer · Innovasis, Inc
See all →- HighAnti-Torque Instrument in Vector Pedicle Screw System Recalled
FDA (Devices) · 2026-08-12
- HighInnovasis spinal fusion devices recalled for implant-inserter interface defect
FDA (Devices) · 2024-09-25
- HighInnovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws
FDA (Devices) · 2018-02-28
- ModerateInnovasis Recalls Opteryx Variable Rescue Screws with Incorrect Size Engraving
FDA (Devices) · 2017-05-31
- ModerateInnovasis Recalls Excella II Titanium Spine Rods Due to Labeling Error
FDA (Devices) · 2016-01-27
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02