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 either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.

Recall number

Z-1203-2012

Recalling firm

Mizuho Orthopedic Systems Inc

Product

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 either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.

Status

Terminated

Initiated

2012-02-27

Posted

2012-03-13

Terminated

2012-09-25

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 device's status prior to and after each use. If customers were unsure of the status of their device, or of its use, they should call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. Customers were asked to respond that the recall has been received, read, understood and communicated to those affected by this activity. A response should be sent via e-mail to couplerII@mizuhois.com. For any questions regarding this recall call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. was sent out on February 27, 2012 to all affected sites. This was after the original was sent to CDRH for review on January 31, 2012, but approval of revisions was not received until 2/27/12.

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.

Lot, serial or model codes

Model 5873

510(k) numbers

not on file

PMA numbers

not on file

Product code

FWZ

Firm FEI

2921578

Firm city

Union City

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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