| Class 2 Device Recall IntraOp | |
Date Initiated by Firm | February 28, 2007 |
Date Posted | December 13, 2007 |
Recall Status1 |
Terminated 3 on December 18, 2008 |
Recall Number | Z-0243-2008 |
Recall Event ID |
38307 |
Product Classification |
Operating room table - Product Code LHN
|
Product | OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included) |
Code Information |
Serial Numbers: 12-15, 17, 19, 21-57, 59-61, 64-67, 70, 71, 73-83, 85-93, 95, 97, 99-134 and 136-141 |
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 |
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. |
Quantity in Commerce | 117 units |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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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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