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.
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: 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
- 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
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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