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Terminated

OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Orthopedic Systems, Inc., Union City, CA

FDA Recall Z-0242-2008 · Posted 2007-12-13

Recalling FirmMizuho Orthopedic Systems Inc
Recall StatusTerminated
Product CodeJEA
Date Initiated2007-02-28
Date Terminated2008-12-18
Product Quantity109 units

Reason for Recall

Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

Firm Action

The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.

Root Cause

Software design

Distribution Pattern

Worldwide: USA product was distributed to 16 wholesale dealers, 212 medical facilities, 14 distributors throughout the US in the following states: AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, WI, WV and WY and to the following countries Taiwan, Australia, German, Japan, Canada, Saudi Arabia, and The UK.

Official Source

View FDA Recall →

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

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