Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction

FDA device recall Z-2493-2012 · posted 2012-09-28 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have o

Action taken

Zimmer sent an Urgent Medical Device Recall dated August 2012 to distributors via electronic mail and Hospital risk managers and surgeons had notifications hand delivered by sales representatives. The recall notice describes the reason for the recall, emphasizes surgical technique to be used, includes instructions for delivering notifications to surgeons and risk managers, instructions for replacing the affected product, and instructions for returning the affected product. Customers were instructed to locate the affected product and contact their sales representative for replacement. Consignees are asked to fill out the Certificate of Delivery, scan it and send back per the instruction provided.

Root cause

Device Design

Status

Terminated

Product code

JWH

Quantity affected

60

Distribution

Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy.

Date initiated

2012-09-07

Date posted

2012-09-28

Date terminated

2014-04-17

Location

Warsaw, IN

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