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

OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G

FDA Recall Z-0423-2019 · Posted None

Recalling FirmAROA Biosurgery, LTD.
Recall StatusTerminated
Product CodeFTM
Date Initiated2018-04-06
Date Terminated2019-04-15
Product Quantity881 total

Reason for Recall

Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.

Firm Action

Beginning in April 2018, customers were visited by representatives and the affected units were replaced.

Root Cause

Other

Distribution Pattern

The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) · 2016-03-15

Official Source

View FDA Recall →

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

↑