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

OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols instruct surgeons on proper surgical technique.

FDA Recall Z-0506-2010 · Posted 2010-01-11

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLZO
Date Initiated2009-08-31
Date Terminated2013-07-17
Product Quantity978

Reason for Recall

Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.

Firm Action

"Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022555ACCOLADE C FEMORAL STEMSHowmedica Osteonics Corp. · 2002-08-26

Official Source

View FDA Recall →

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

↑