Recall Z-1203-2012 ยท FWZ Operating Room Accessories Table Tray
Mizuho Orthopedic Systems Inc
Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing
| Date | Mar 13, 2012 (initiated Feb 27, 2012) |
| Status | Terminated |
| Reason | Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a complaint. |
| Root cause | Labeling design |
| Action | Mizuhosi OSI sent an Urgent Medical Device Recall Communication letter dated February 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Mizuho OSI provided their customers of the affected product an updated Owner's manual. Customers were instructed to ensure they remove their existing Owner's Manual from use and repalce with the current Owner's Manual. If customers were unsure of the device's use, they should refer to the included Owner's Manual and ensure all users are properly trained, able to assess the devic |
| Quantity | 1077 devices |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Japan, South Korea, Lebanon, Malaysia, Netherlands, New Zealand, South Arabia, Singapore, Germany, South Africa, Spain, Sweden, UA. E., United Kingdom, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.