Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1276-2013 · Posted 2013-05-08

Recalling FirmMedshape Solutions, INC.
Recall StatusTerminated
Product CodeMBI
Date Initiated2013-04-04
Date Terminated2013-08-07
Product Quantity26

Reason for Recall

Expiration date on the patient label and date on the product carton were not the same.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111471EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)Medshape Solutions, Inc. · 2011-06-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑