Device recall: REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
an individual recalling firm (name withheld) (San Daniele Del Friuli, N/A) initiated this device recall on 30 May 2023; FDA lists 2 product records under event 92459, classified Class II.
FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), San Daniele Del Friuli, N/A, Italy. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"Due to manufacturing issue, their is a potential for peripheral holes to be out of specification."
Distribution
"US Nationwide distribution in the states of MI, IL, ND, MO, OK."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2009-2023 | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R | 13 units | Class II | Ongoing | 5 Jul 2023 |
| Z-2010-2023 | REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R | 13 units | Class II | Ongoing | 5 Jul 2023 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to manufacturing issue, their is a potential for peripheral holes to be out of specification."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of MI, IL, ND, MO, OK."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.