Data Foundry

Medical device recalls 2013

ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230 — Class II medical device recall Z-1276-2013

Terminated recall by Medshape Solutions, INC., reported 2013-05-15, distributed nationwide. Expiration date on the patient label and date on the product carton were not the same.

Recall numberZ-1276-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedshape Solutions, INC., Atlanta, GA, United States
Recall initiated2013-04-04
Classified2013-05-08
Reported by FDA2013-05-15
Terminated2013-08-07
DistributedNationwide (US)
Quantity26
Reason classeslabeling
Lot numbers113011-002
Model numbers1101-00-1230

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1276-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.