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

Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012

FDA Recall Z-0204-06 · Posted 2005-11-26

Recalling FirmOrmco Corporation
Recall StatusTerminated
Product CodeDYW
Date Initiated2005-11-03
Date Terminated2006-01-11
Product Quantity1420

Reason for Recall

Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

Firm Action

Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052477DAMON 3 MODIFIEDOrmco Corp. · 2005-11-30

Official Source

View FDA Recall →

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

↑