Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 P

FDA device recall Z-0538-2013 · posted 2012-12-18 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

Action taken

Zimmer sent "URGENT MEDICAL DEVICE RECALL" letter dated November 19, 2012 to Distributors, Risk Managers/ Implanting Surgeons, and direct accounts. The notice describes the product, problem, risks and actions to be taken. Consignees were instructed to immediately locate, quarantine and return affected product with the completed Inventory Return Certification form to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 (US accounts) or Zimmer International Logistics GmbH, ATTN: Fao Tanja Herold (Recall Warsaw), Max-Immelmann-Allee 12 79427 Eschbach Germany for international accounts. If an implant is removed from customer inventory, they were directed to provide a copy of the Risk Manager letter upon retrieval of that implant(s) to ensure all facilities are aware of the removal. Surgeons are asked to consider risk information in the letter should a patient present with unexplained symtoms. Hospitals that received direct shipments from the Warsaw Distribution Center will be sent a copy of the Risk Manager letter directly. Questions and concerns along with information on any implanted product is to be addressed to CorporateQuality.PostMarket@zimmer.com using the provided spreadsheet or contact Zimmer at 1-800-447-5633.

Root cause

Process change control

Status

Terminated

Product code

JDC

Quantity affected

17

Distribution

Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.

Date initiated

2012-11-19

Date posted

2012-12-18

Date terminated

2014-04-17

Location

Warsaw, IN

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