BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Meta

FDA device recall Z-0572-2011 · posted 2010-12-09 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KWT

Quantity affected

13,093 total reamers in distribution.

Distribution

Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia,

Date initiated

2010-09-10

Date posted

2010-12-09

Date terminated

2012-09-14

Location

Warsaw, IN