Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues
Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (difficulty assembling) rather than a direct safety risk like contamination or structural failure causing injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Limacorporate S.p.A. is recalling 110 units of SMR Shoulder/Spalla Trial Humeral Heads. The affected products include diameters of .42 mm, .44 mm, and .46 mm, with reference numbers 9013.22.425, 9013.22.445, and 9013.22.465. These devices are intended for use in shoulder implant surgery.
The recall was initiated because the dimensions of the mating features of the recalled products are out of specification. This defect causes the device to be difficult to assemble. The affected lot numbers are 14AA234, 14AA235, and 14AA233.
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 facilities should stop using these specific trial heads and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Limacorporate S.p.A
- Affected units
- 110
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 (3)
- Lot Numbers: 14AA234
- 14AA235
- 14AA233
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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