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

OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054

FDA Recall Z-0825-2008 · Posted 2008-02-14

Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeMQV
Date Initiated2007-10-23
Date Terminated2008-04-15
Product Quantity19 units

Reason for Recall

Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive)

Firm Action

Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS

Official Source

View FDA Recall →

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

↑