FDA Medical Device Recalls (openFDA)
Medshape Solutions, INC.: 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.
- Recall number
- Z-1276-2013
- Recalling firm
- Medshape Solutions, INC.
- 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.
- Status
- Terminated
- Initiated
- 2013-04-04
- Posted
- 2013-05-08
- Terminated
- 2013-08-07
- Reason
- Expiration date on the patient label and date on the product carton were not the same.
- Root cause
- Error in labeling
- Action
- Medshape sent an "URGENT: MEDICAL DEVICE RECALL" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
- Quantity
- 26
- Distribution
- Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
- Lot, serial or model codes
- Lot No. 113011-002
- 510(k) numbers
- ["K111471"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3007593722
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28