Secur-Fit MAX Secure-FIT Plus Max Surgical Protocol. Surgical protocols instruct surgeons on proper surgical technique.
FDA Recall Z-0508-2010 · Posted 2010-01-11
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLZO
Date Initiated2009-08-31
Date Terminated2013-07-17
Product Quantity3,510
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.