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Terminated

2.5mm Hex Driver

FDA Recall Z-0558-04 · Posted 2004-02-27

Recalling FirmU&I America
Recall StatusTerminated
Product CodeMNI
Date Initiated2004-01-14
Date Terminated2004-03-24
Product Quantity320 units

Reason for Recall

Reports of hex driver tips breaking off or becoming worn or stripped.

Firm Action

The only consignee was notified by letter on 1/14/2003.

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 · 2003-06-27K031595U & I AMERICA SPINAL HOOK SYSTEMU&I Corp., America · 2003-06-24K024096OPTIMA, SPINAL SYSTEMU&I Corp., America · 2003-03-12K020279FOREX CORPORATION, OPTIMA, SPINAL SYSTEMForex Corp. · 2002-06-20

Official Source

View FDA Recall →

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

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