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Recall Observatory FDA recall evidence

Device product

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

Z-2025-2025

May 19, 2025

Class II

Product summary

Firm
Limacorporate S.p.A
Event
Event 96911
Status
Ongoing
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-2025-2025

Official wording

Reason: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

Code information: Lot number 2421400/UDI: 08033390201834

Distribution pattern: Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.