| Class 2 Device Recall ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT | |
Date Initiated by Firm | September 10, 2010 |
Date Posted | December 09, 2010 |
Recall Status1 |
Terminated 3 on September 14, 2012 |
Recall Number | Z-0570-2011 |
Recall Event ID |
56731 |
510(K)Number | K041549 K050761 K052906 K060704 |
Product Classification |
Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
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Product | ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/018-13.
The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. 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. |
Code Information |
Catalog Number 00-4310-008/018-13 All Lot Numbers |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | 574-372-4807 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 9,790 total distal pilots 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KWT
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