Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

FDA device recall Z-1798-2015 · posted 2015-06-15 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.

Action taken

On 4/22/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications, dated April 22, 2015 were sent to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are required to immediately locate and remove the affected product from circulation, follow the instructions on the "Response Form," and e-mail a copy of the completed form to the designated e-mail address prior to returning the product. Additionally, if the affected product has been further distributed, the necessary personnel must notified via the "Dear Risk/Recall Manager" notice. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root cause

Process control

Status

Terminated

Product code

HRY

Quantity affected

27

Distribution

Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.

Date initiated

2015-04-22

Date posted

2015-06-15

Date terminated

2016-03-22

Location

Warsaw, IN

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