Limacorporate Recalls SMR Shoulder Trial Heads Due to Assembly Issues
Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a manufacturing defect causing assembly difficulty, which is a functional issue rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Limacorporate S.p.A is recalling 93 units of SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor (REF 9013.30.021) and SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor (REF 9013.30.031). These devices are used in shoulder implant surgery.
The recall was initiated because the dimensions of the mating features of the recalled products are out of specification, which causes the device to be difficult to assemble. The affected lot numbers are 14AA146 and 14AA153.
The products were distributed in the United States to the states of Ohio, Texas, North Carolina, New York, California, Florida, Kansas, Alabama, Michigan, Montana, Colorado, Missouri, Nevada, Washington, Minnesota, and Louisiana, as well as internationally to Australia. Healthcare providers and patients should contact Limacorporate S.p.A for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
- Manufacturer
- Limacorporate S.p.A
- Affected units
- 93
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 Numbers: 14AA146 and 14AA153
Distribution
Part of a larger recall action
This product is one of 2 recalled by Limacorporate S.p.A under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Limacorporate S.p.A
See all →- HighPRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall
FDA (Devices) · 2025-07-02
- HighPRIMA 2MM Eccentrical Adaptor With Screw Sterile Medical Device
FDA (Devices) · 2025-07-02
- HighTEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern
FDA (Devices) · 2025-01-01
- HighPRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk
FDA (Devices) · 2024-01-24
- HighMedical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
FDA (Devices) · 2023-12-20
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12