Medicrea Universal Counter Torque Recalled Due to Incompatibility with Nut Driver
Medicrea International is recalling 3 units of Universal Counter Torque for the Pass TULIP Spinal System because they are incompatible with the T30 nut driver.
What this means for you
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, and the hazard is a functional incompatibility between medical device components without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Medicrea International is recalling 3 units of the Universal Counter Torque (Ref: A22020500) used with the Pass TULIP Spinal System. The recall is due to the product being incompatible with the T30 nut driver (Ref: A22020220).
The affected units are identified by Lot Number 19H0108 and have an expiration date of 19/08/2029. These units were distributed in California and Florida.
Consumers and healthcare providers should stop using the affected Universal Counter Torque units and contact Medicrea International for further instructions.
The recalled product
- Product
- Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
- Manufacturer
- Medicrea International
- Hazard
- Affected units
- 3
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 (1)
- Lot Number:19H0108 Exp.Date: 19/08/2029
Distribution
Related recalls
Same manufacturer · Medicrea International
See all →- ModerateSpinal instrument sets recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- ModerateUniversal implant inserters recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- HighSpine Surgery Planning Software Calculation Errors in Rod Planning Parameters
FDA (Devices) · 2025-02-12
- HighIntervertebral fusion device recalled for packaging non-conformity issue
FDA (Devices) · 2023-08-30
- ModerateCervical intervertebral fusion devices recalled for packaging defect
FDA (Devices) · 2023-08-30
Same hazard · incompatibility
See all →- ModerateZimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information
FDA (Devices) · 2025-04-30
- ModerateZimmer Biomet Ceramic Hip Prosthesis Heads Lack Stem Compatibility Information
FDA (Devices) · 2025-04-30
- HighAMT Mini Enteral Extension Set Recalled for Incorrect Connector Type
FDA (Devices) · 2025-01-15
- HighPerfusor Space infusion pump syringe incompatibility may cause dosing error
FDA (Devices) · 2024-07-31
- HighINOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator
FDA (Devices) · 2022-09-21