Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthriti

FDA device recall Z-0111-2017 · posted 2016-10-18 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.

Action taken

On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. 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. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a call back the next business day. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.

Root cause

Labeling mix-ups

Status

Terminated

Product code

JWH

Quantity affected

5

Distribution

Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.

Date initiated

2016-08-09

Date posted

2016-10-18

Date terminated

2017-05-17

Location

Warsaw, IN

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