Zimmer Inc.: BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4301-006/018-00. The intramedullary reamer manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The reamer is used to open the mid to distal humeral canal to accept the implant. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. is used to open the mid to distal humeral canal to accept the implant.

Recall number

Z-0572-2011

Recalling firm

Zimmer Inc.

Product

BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4301-006/018-00. The intramedullary reamer manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The reamer is used to open the mid to distal humeral canal to accept the implant. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. is used to open the mid to distal humeral canal to accept the implant.

Status

Terminated

Initiated

2010-09-10

Posted

2010-12-09

Terminated

2012-09-14

Reason

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.

Root cause

Device Design

Action

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.

Quantity

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, Canada, and Thailand.

Lot, serial or model codes

Catalog Number 00-4301-006/018-00.   All lot numbers.

510(k) numbers

not on file

PMA numbers

not on file

Product code

KWT

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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