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TRABECULAR METAL" SHOULDER REAMER CASE used for… recallZ-0573-2011 · Zimmer Inc. · initiated Sep 10, 2010

Terminated All recalls posted in December 2010

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

The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.

FDA root cause category: Device Design

What the company is doing

Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to: a. provide the Dear Surgeon (Urgent Device Correction) letter and revised surgical technique directly to surgeons and risk managers at facilities using the device or b. provide a list of facilities and surgeons using the TM Humeral and TM Reverse shoulder systems to the Zimmer Recall Coordinator, and c. destroy previous versions of the surgical technique, and d. inform users of when the new surgical technique, instrument case, distal reamers, and distal pilots will be shipped to them based on communication from Zimmer, Inc. Handling of returned product: HCPs were notified to return all of the distal pilots in the scope back to Zimmer which were to be be destroyed once the recall has been completed. They will also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by Zimmer Sales Representatives. For questions regarding this recall call (574) 371-8852.

Recall details

Recall number
Z-0573-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 10, 2010
Posted by the FDA
Dec 9, 2010
Recalling firm
Zimmer Inc.
Quantity
13,093 total reamers in distribution.
Product code
KWT
FDA submissions
K041549, K050761, K052906, K060704
Distribution
Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.

Product description

TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00. The intramedullary reamer is used to open the mid to distal humeral canal to accept the implant.

Code information (models, lots, serial numbers)

Catalog Number 00-4312-020-00.   All lot numbers.

Other devices under the same FDA submission

35 devices cleared under K041549, K050761, K052906, K060704 — 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 56731).

Sources and updates

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