CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate recalled
Limacorporate S.p.A is recalling REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, distributed nationwide in the US. The recall was initiated on 30 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2010-2023
- FDA event ID
- 92459
- Recalling firm
- Limacorporate S.p.A, San Daniele Del Friuli, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2023
- FDA classified
- 27 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 May 2023 | Recall initiated by company | |
| 27 Jun 2023 | Classified by FDA | +28 days |
| 5 Jul 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Where it was distributed
US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Questions about this recall
Is REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate recalled?
Yes. Limacorporate S.p.A recalled REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate on 30 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2010-2023.
Why was it recalled?
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Which lots are affected?
UDI-DI: 08033390244893; All Lots
Where was it sold?
US Nationwide distribution in the states of MI, IL, ND, MO, OK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Limacorporate S.p.A
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|---|---|---|---|---|---|
| Device | CLASS II | Prima Eccentrical Adaptor With Screw recalled by Limacorporate S.p.A | Limacorporate S.p.A | Sterility | Nationwide |
| Device | CLASS II | Prima Eccentrical Adaptor With Screw recalled by Limacorporate S.p.A | Limacorporate S.p.A | Sterility | Nationwide |
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