Trabecular Metal" Reverse Shoulder System
Reported: March 5, 2014 Initiated: October 17, 2013 #Z-1079-2014
Product Description
Trabecular Metal" Reverse Shoulder System
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 73,002 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Trabecular Metal" Reverse Shoulder System. Recalled by Zimmer, Inc.. Units affected: 73,002 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1079-2014.
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