FDA Recalls PRIMA Orthopedic Adaptor for Missing Position-Identification Marking
Limacorporate is recalling the PRIMA 4MM Eccentrical Adaptor due to potentially missing black laser markings that identify proper positioning. The missing marking could result in improper device positioning during surgical procedures.
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: This is an FDA Class II medical device recall for a surgical positioning adaptor where the identification marking may be missing. This constitutes a risk-of-harm scenario where improper positioning could occur. Per the regulatory rubric, this qualifies as High severity.
Plain-English summary
Limacorporate S.p.A. is recalling the PRIMA 4MM Eccentrical Adaptor with Screw (Reference: 1367.15.704, Sterile) due to a potential manufacturing defect. The black laser marking used to identify correct positioning may be missing on certain units in Lot 2421400 (UDI: 08033390201834).
The missing positioning marking could result in improper placement of the device during surgical procedures, potentially compromising the adaptor's intended function. The recalled units represent 9 units distributed nationwide to Virginia, Florida, South Carolina, Mississippi, New York, and Texas, as well as internationally to Italy, Poland, and France.
Affected healthcare facilities and practitioners should immediately discontinue use of recalled units from Lot 2421400 and contact Limacorporate for guidance on replacement or proper device disposition.
The recalled product
- Product
- PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- Manufacturer
- Limacorporate S.p.A
- Hazard
- marking-missing
- positioning-error
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.
Related recalls
Same category
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03