Medshape ExoShape Soft Tissue Fastener Recalled for Labeling Date Discrepancy
Medshape Solutions is recalling 26 ExoShape Soft Tissue Fasteners because the expiration date on the patient label did not match the date on the product carton.
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 and involves a minor labeling error (date discrepancy) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or labeling issues.
Plain-English summary
Medshape Solutions, INC. is recalling 26 units of ExoShape Soft Tissue Fastener 12 mm x 30 mm (REF 1101-00-1230). The product is used for the fixation of ligaments, tendons, or soft tissue grafts to bone.
The recall was initiated because the expiration date on the patient label and the date on the product carton were not the same. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected units are from Lot No. 113011-002. The products were distributed nationwide, including in the states of Colorado, Florida, Georgia, Iowa, Maryland, Missouri, Oregon, Texas, Vermont, Virginia, and Wisconsin. Healthcare providers and patients should contact Medshape Solutions for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
- Manufacturer
- Medshape Solutions, INC.
- Hazard
- Affected units
- 26
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 No. 113011-002
Distribution
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