Trabecular Metal" Reverse Shoulder System
FDA device recall Z-1079-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.
- Action taken
- In November and December 2012 Sales staff were provided updated surgical technique and associated video to share with current customers, surgeons, and risk managers. October 17, 2013 Distributors ( via E-mail),and Risk Managers and Surgeons (via traceable courier) were sent written Urgent Recall notifications of these labeling changes. Current customers are identified through an invoice search and distribution history for the affected devices for the past 12 months, since 9/1/12.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWT
- Quantity affected
- 73,002 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
- Date initiated
- 2013-10-17
- Date posted
- 2014-02-24
- Date terminated
- 2014-09-12
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K052906) | Zimmer, Inc. | 2005-12-19 |