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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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