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

CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.

FDA Recall Z-2585-2010 · Posted 2010-09-28

Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeFZW
Date Initiated2010-01-29
Date Terminated2011-01-12
Product Quantity149

Reason for Recall

There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.

Firm Action

Recall Notification Letters were sent to customers on January 29, 2010. Customers were requested to complete and return a Customer Response Form indicating the number of products available for return and number distributed. Each distributor was asked to notifiy their customers if the product was further distributed.

Root Cause

Process control

Distribution Pattern

Distributed throughout U.S. and Internationally to Arab Emirates, Belgium, Canada, China, Columbia, Cyprus, Germany, Denmark, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Republic of Korea, Lithuania, Morocco, Malaysia, Poland, Portugal, Saudi Arabia, El Salvador, Thailand, Taiwan and Viet Nam. Domestic Distribution to CA, FL, GA, IL, IN, KS, MI, MT, NY, OH, PA, TX, and WA.

Official Source

View FDA Recall →

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

↑