Agency classClass IIOur severity:High FDA (Devices)·Z-2009-2023·Announced 2023-07-05

Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes

Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.

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 is a Class II medical device recall involving a manufacturing defect in an implantable orthopedic component. It qualifies as High per the rubric criterion for risk-of-harm products where injury has not yet been reported; no illnesses or injuries are mentioned in the source material.

Plain-English summary

Limacorporate S.p.A is recalling REF 1975.14.500 Prima TT Genoid Monoblock Reverse TT Baseplates (STERILE) due to a manufacturing issue. The affected orthopedic implant devices may have peripheral holes that are out of specification.

This recall involves 13 units distributed nationwide in Michigan, Illinois, North Dakota, Missouri, and Oklahoma. The affected devices are identified by UDI-DI 08033390244824 across all lot numbers.

Healthcare providers who have distributed or implanted these devices should contact Limacorporate for instructions and guidance. Patients who have received this implant should consult their healthcare provider if they have any questions or concerns about their implant.

The recalled product

Product: REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Manufacturer: Limacorporate S.p.A
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
structural-defect
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: 08033390244824
All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Limacorporate S.p.A

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