Device Recall Integra CUSA Excel Sterile Torque Wrench (23 kHz) 의 리콜

Recall

67902

Class 2

Z-1522-2014

2014-03-10

2014-04-29

Terminated

United States

2015-02-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126584

Some 23 khz torque wrenches were incorrectly assembled and contained a 36 khz hex wrench insert instead of the 23 khz hex wrench insert.

Integra sent an Urgent: Voluntary Medical Device Recall letter dated March 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. Integra is asking that you do the following: 1. Review your unused inventory of 23 kHz CUSA Sterile Torque Wrenches and determine if they are on the affected lot number list on the next page and if they are still in the box. 2. Complete the attached form. - If you do not have an affected lot number on the list (see page 2), YOU CAN CONTINUE TO USE THE WRENCHES. Check the box I do not have any affected products on the list - If you do have product(s) on the affected lot number list, AND THEY ARE STILL IN THE BOX, determine if the box also has a green dot sticker as in the photo below. If so, YOU CAN CONTINUE TO USE THE WRENCHES. Check the box I do not have any affected products on the list on page 2. 3. Complete the other information on the form if you do or do not have affected products, return the form by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, if you have noted you have affected products Customer Service will contact you and provide an RMA number and directions to return the product, as well as input an order to replace the quantity you indicated on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.