Recall Z-0576-2011
Zimmer Inc. · initiated September 10, 2010
Product
Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. 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. System is 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.
Codes / lots: Surgical Technique, Catalog Number: 97-4309-003-00, Rev. 4.
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: Device Design
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.
Details
- Recall number
- Z-0576-2011
- Initiated
- September 10, 2010
- Posted by FDA
- December 9, 2010
- Terminated
- September 14, 2012
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- 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.
- Recalling firm
- Zimmer Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0570-2011 | ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | 09/10/2010Terminated |
| Z-0571-2011 | ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | 09/10/2010Terminated |
| Z-0572-2011 | BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | 09/10/2010Terminated |
| Z-0573-2011 | TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | 09/10/2010Terminated |
| Z-0574-2011 | Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | 09/10/2010Terminated |
| Z-0575-2011 | Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | 09/10/2010Terminated |