High FDA (Devices)·Z-2025-2025·Announced 2025-07-02

PRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall

Limacorporate S.p.A is recalling PRIMA 4MM Eccentrical Adaptor with Screw devices because the black laser marking used to identify positioning may be missing. The defect could affect proper device placement during use.

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: The recall is classified as FDA Class II. While no illnesses or injuries are reported, the missing laser marking creates a risk that the device could be improperly positioned during use, which is a risk-of-harm scenario for a medical device where injury has not yet been reported, meeting the High (score 3) threshold.

Plain-English summary

Limacorporate S.p.A is recalling the PRIMA 4MM Eccentrical Adaptor with Screw (Reference: 1367.15.704) due to the potential that the black laser marking used to identify the position may be missing on affected units.

The laser marking serves to identify proper positioning of the adaptor during use. If the marking is missing, users may not be able to correctly determine the device's orientation, which could result in improper placement.

The recalled product was distributed worldwide, including in the United States in the states of Virginia, Florida, South Carolina, Mississippi, New York, Texas, and internationally in Italy, Poland, and France. The affected lot is 2421400 (UDI: 08033390201834). Nine units have been identified.

Healthcare facilities and users who have received this product should stop use and contact Limacorporate S.p.A for instructions on return or replacement.

The recalled product

Product: PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Manufacturer: Limacorporate S.p.A
Category: Medical Device — Orthopedic / Surgical Component
Hazard: missing-marking
improper-positioning
Affected units: 9

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 (1)

Lot number 2421400/UDI: 08033390201834

Distribution

Distributed nationwide across the United States.

The notice also names 6 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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Same hazard · missing marking