Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect
Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.
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 3/5 (High).
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: This FDA Class II medical device recall involves a manufacturing defect with no reported injuries or illnesses. It qualifies as High severity because it represents a risk-of-harm product (orthopedic surgical implant) where injury has not been reported, meeting the rubric criterion for this classification.
Plain-English summary
Limacorporate S.p.A. is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate, Sterile. This is a medical device baseplate.
The recall is due to a manufacturing issue that creates a potential for peripheral holes to be out of specification.
The affected devices were distributed nationwide to medical facilities in the states of Michigan, Illinois, North Dakota, Missouri, and Oklahoma. The product is identified by UDI-DI: 08033390244893 and the recall applies to all lots.
The recalled product
- Product
- REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
- Manufacturer
- Limacorporate S.p.A
- 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 (2)
- UDI-DI: 08033390244893
- All Lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Limacorporate S.p.A under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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