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Coonrad/Morrey New Ulnar Revision Kit for Use with… recallZ-0538-2013 · Zimmer, Inc. · initiated Nov 19, 2012

Class II Terminated All recalls posted in December 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 .

FDA root cause category: Process change control

What the company is doing

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 [email protected] using the provided spreadsheet or contact Zimmer at 1-800-447-5633.

Recall details

Recall number
Z-0538-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 19, 2012
Posted by the FDA
Dec 18, 2012
Recalling firm
Zimmer, Inc.
Quantity
17
Product code
JDC
FDA submissions
K001989
Distribution
Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.

Product description

Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

Code information (models, lots, serial numbers)

Catalog 32-8105-029-00-29; Lot 61722176

Other devices under the same FDA submission

13 devices cleared under K001989 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63641).

Sources and updates

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