FDAAugust 14, 2015device
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
What to do
FDA enforcement status: Terminated
Brands named
limacorporate s p alimacorporate
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile2025-05-19
- FDAPRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile2025-05-19
- FDATEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.2024-10-02
- FDAPHYSICA HPS Tibial Liner #6 H10 REF 6539.54.6102023-10-27
- FDAPRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15...2023-08-29
- FDAREF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R2023-05-30
- FDAREF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R2023-05-30
- FDASMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.2102023-02-21
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