Z-1276-2013Class II

ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons...

Name: Z-1276-2013 ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons...
Creator: Medshape Solutions, INC.
Published: 2013-04-04
License: https://open.fda.gov/license/

Medshape, Inc. / initiated 2013-04-04 / Terminated / root cause: labeling and UDI

FDA source

Medshape Solutions, INC. began a recall of 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 on 2013-04-04. FDA classified it as Class II and gives the reason as "Expiration date on the patient label and date on the product carton were not the same". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1276-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-05-08
Terminated: 2013-08-07
Recalling firm: Medshape, 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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Expiration date on the patient label and date on the product carton were not the same.
Root cause tag: labeling and UDI
FDA 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 in commerce: 26
Distribution: Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
Product codes and lots: Lot No. 113011-002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1276-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-08

Product code MBI

K111471Class IIExoshape (Tm) Interference Fixation Device Model 1100-00-Xxxx (Varies by Size)Medshape Solutions, Inc. / cleared 2011-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)