Implantech Recalls Gelzone Shoulder Sleeves Due to Velcro Closure Defect
Implantech Associates Inc is voluntarily recalling Gelzone Shoulder Sleeves because the Velcro closure may not meet robustness requirements.
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 describes a functional defect (Velcro robustness) without reporting any injuries, hospitalizations, or specific health hazards, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Implantech Associates Inc has initiated a voluntary recall of the Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. The recall involves 300 units of the product, which is used for limb support and/or elevation.
The recall was initiated because the product may not satisfy customer requirements for the robustness of the Velcro closure. The source text does not report any specific injuries or illnesses associated with this defect.
The affected products were distributed nationwide in the United States (specifically in California, Arizona, Illinois, North Carolina, and Colorado) and in South Africa. Consumers should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
- Manufacturer
- Implantech Associates Inc
- Hazard
- Affected units
- 300
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 (2)
- Catalog Number SLV634
- Lot Number 852766.
Distribution
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