FDA recall record · openFDA

Limacorporate S.p.A

9 FDA recalls on record (2023–2025) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be 2

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. 2

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. 1

Due to incorrect product labeling 1

Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surge 1

Recalls

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile Class II 2025-05-19 PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile Class II 2025-05-19 TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented to Class II 2024-10-02 TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) Class II 2023-01-25 PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 Class II 2023-10-27 REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Class II 2023-05-30 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.50 Class II 2023-08-29 SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 Class II 2023-02-21 REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Class II 2023-05-30

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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