ExoShape Soft Tissue Fastener 12 mm x 30 mm recall
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.
Why was ExoShape Soft Tissue Fastener 12 mm x 30 mm recalled?
Expiration date on the patient label and date on the product carton were not the same.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 113011-002
- 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.
- Recalling firm
- Medshape Solutions, INC.
- Quantity
- 26
- Distribution
- Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
- Recall date
- May 15, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)