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.
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, 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
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