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Terminated

Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053

FDA Recall Z-0717-03 · Posted 2003-04-10

Recalling FirmLinvatec Corp DBA Linvatec/Hal
Recall StatusTerminated
Product CodeHWE
Date Initiated2003-01-24
Date Terminated2012-07-07
Product Quantity74

Reason for Recall

The Footswitch functions of the left and right foot pedals may be reversed in some units.

Firm Action

The firm telephoned and mailed a Recall Notification letter with response form to all Accounts beginning on 1/24/03. Distributors were asked to subrecall down to the medical facility level. Recalled devices are to be returned to Linvatec for testing.

Root Cause

Other

Distribution Pattern

Nationwide, worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942660HALL MICROCHOICE ELECTRIC POWERED SYSTEMHall Surgical, Division of Zimmer, Inc. · 1994-09-07

Official Source

View FDA Recall →

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

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