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Terminated

Optima Large Poly Screw Driver

FDA Recall Z-1183-03 · Posted 2003-08-27

Recalling FirmU&I America
Recall StatusTerminated
Product CodeMNI
Date Initiated2003-08-18
Date Terminated2003-11-19
Product Quantity116 units.

Reason for Recall

Reports of pieces chipping off the tip of screwdriver during use.

Firm Action

Consignee was notified by letter on 8/18/2003

Root Cause

Other

Distribution Pattern

MN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031585U&I, OPTIMA, SPINAL SYSTEMU&I Corp., America · 2003-06-27

Official Source

View FDA Recall →

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

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