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FDA device recall Z-1384-2013 · posted 2013-05-24 · Terminated

Recall details

Recalling firm

Orthopedic Alliance LLC

Reason for recall

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Action taken

A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Root cause

Labeling design

Status

Terminated

Product code

HWC

Quantity affected

5 units

Distribution

Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Date initiated

2013-02-20

Date posted

2013-05-24

Date terminated

2014-03-26

Location

Murrieta, CA