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U.S. Department of Health and Human Services

Class 2 Device Recall OSI ProFx

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 Class 2 Device Recall OSI ProFxsee related information
Date Initiated by FirmFebruary 28, 2007
Date PostedDecember 13, 2007
Recall Status1 Terminated 3 on December 18, 2008
Recall NumberZ-0242-2008
Recall Event ID 38307
Product Classification Orthopedic Surgery Table - Product Code JEA
ProductOSI 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
Code Information Serial Numbers: 1-12, 14-21, 23,24, 26-39, 41-43, 45-54, 56-59, 62-76, 78-100, and 102-119
FEI Number 2921578
Recalling Firm/
Manufacturer		 Mizuho Orthopedic Systems Inc
30031 Ahern Ave
Union City CA 94587-1234
For Additional Information Contact
510-429-1500
Manufacturer Reason
for Recall		Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
FDA Determined
Cause 2		Software design
ActionThe 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.
Quantity in Commerce109 units
DistributionWorldwide: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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