Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifica

FDA device recall Z-1203-2012 · posted 2012-03-13 · Terminated

Recall details

Recalling firm

Mizuho Orthopedic Systems Inc

Reason for recall

Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a complaint.

Action taken

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.

Root cause

Labeling design

Status

Terminated

Product code

FWZ

Quantity affected

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 Ar

Date initiated

2012-02-27

Date posted

2012-03-13

Date terminated

2012-09-25

Location

Union City, CA