Optima Spinal System and Spinal Hook System, set screw component.
FDA Recall Z-1438-04 · Posted 2004-09-08
Recalling FirmU&I America
Recall StatusTerminated
Product CodeMNI
Date Initiated2004-08-10
Date Terminated2005-11-29
Product Quantity200 set screws
Reason for Recall
Threads on a set screw, as a component of a spinal fixation system, may break off during use.
Firm Action
Consignee was notified by letter on 08/10/2004.
Root Cause
Other
Distribution Pattern
CA
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.