The FDA announced on Feb. 21, 2023, that Limacorporate S.p.A. is recalling the SMR TT Hybrid glenoid Std - Peg S shoulder prosthesis because it was manufactured without tantalum markers. This defect prevents correct radiographic assessment of the implant position.
How to tell if you have it
- Brand: Limacorporate
- Product: SMR TT Hybrid glenoid Std - Peg S
- REF: 1379.59.210
- UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
- Distribution: Missouri
The hazard
The shoulder glenoid fossa prosthesis was manufactured without tantalum markers. In the absence of these markers, a correct radiographic assessment of the hybrid glenoid position cannot be performed via standard imaging.
Context
GovInfoNow's records show Limacorporate S.p.A has issued 8 other recalls since Sept. 8, 2017. Recent brand recalls include a May 19, 2025 recall for the PRIMA 2MM Eccentric Adaptor due to missing screw risk and an Oct. 2, 2024 recall for TEMA Elbow Prostheses involving potential surgical risk. Other recent recalls of similar products include the July 13, 2026 Straumann GM Helix Dental Implant Recall for packaging mismatch risk and the March 17, 2026 Straumann Custom Abutment Ti Recall for material mix-up risk.