Recall Z-1276-2013— Medshape Solutions, INC.

Name: FDA recall Z-1276-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-04

Class II · Terminated

Class II FDA medical device recall by Medshape Solutions, INC., initiated 2013-04-04, terminated 2013-08-07. It names one FDA 510(k) clearance: K111471. 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.. Reason: Expiration date on the patient label and date on the product carton were not the same..

Recalling firm: Medshape Solutions, INC.
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Terminated: 2013-08-07
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K111471 — EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)Medshape Solutions, Inc.·cleared 2011-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.