Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER Boom, REF 00-590

FDA device recall Z-1987-2011 · posted 2011-04-14 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.

Action taken

The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Instructions for Handling of Affected Product: 1) Stop using the devices and to quarantine immediately 2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder 3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification 4) Fax copy of completed form to (574) 372-4265 5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580 A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available. Instructions for Health Care Professional Notification 1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form 2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265 Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons. Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131. ADDENDUM INFO The information listed above was updated to include the additional 5

Root cause

Device Design

Status

Terminated

Product code

MBH

Quantity affected

207

Distribution

Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Net

Date initiated

2011-03-14

Date posted

2011-04-14

Date terminated

2013-03-19

Location

Warsaw, IN

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