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Terminated

Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.

FDA Recall Z-0558-2010 · Posted 2009-12-22

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2009-11-02
Date Terminated2010-10-15
Product Quantity71

Reason for Recall

The power cord female receptacle is not recessed sufficiently and may present a shock hazard.

Firm Action

Zimmer sales staff were notified by letter dated 11/2/09 and instructed to locate the units and to upgrade the cords and to notify consignees by copy of a letter addressed to risk managers and dated 11/2/09.

Root Cause

Device Design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALOrthosoft, Inc. · 2007-09-19K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003Orthosoft, Inc. · 2007-07-20K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002Orthosoft, Inc. · 2006-04-28

Official Source

View FDA Recall →

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

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