PRIMA 2MM Eccentrical Adaptor With Screw Sterile Medical Device
Limacorporate is recalling PRIMA 2MM Eccentrical Adaptor With Screw sterile devices because the black laser marking used to identify position may be missing.
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: FDA Class II medical device recall where a critical identification marking (position indicator) may be missing, creating a risk of improper device placement during surgical or clinical use. No reported illnesses or injuries are mentioned in the source, but the hazard is not merely theoretical—misalignment due to missing identification could lead to adverse outcomes.
Plain-English summary
Limacorporate S.p.A is recalling the PRIMA 2MM Eccentrical Adaptor With Screw, Sterile (Reference 1367.15.702, Lot 2416658/UDI: 08033390201827). The black laser marking on the adaptor, which is used to identify the correct position, may be missing on affected units.
The potential for a missing position identifier could affect proper device placement and alignment during use. A total of 19 units have been recalled. The devices were distributed worldwide, including in the United States in Virginia, Florida, South Carolina, Mississippi, New York, Texas, and internationally in Italy, Poland, and France.
Patients and healthcare providers who have received this device should contact their healthcare facility or Limacorporate S.p.A to verify whether their unit is affected and to arrange a replacement if necessary.
The recalled product
- Product
- PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
- Manufacturer
- Limacorporate S.p.A
- Hazard
- missing-marking
- misalignment-risk
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 2416658/UDI: 08033390201827
Distribution
Distributed nationwide across the United States.
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