Reported Mar 5, 2014 · Terminated
Trabecular Metal" Reverse Shoulder System
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Trabecular Metal" Reverse Shoulder System
- Lot codes and dates
114 of 114 codes
610256136100983061038635610313856102150761021506610169076100983461006493610064926099923960993837609938366098729560982839609828386097097460970973609502536096442560946627609709466096442660943695609404486095025160946624609404496092740560934492609005426092740660919029609146176091902860900543608931806089318160906211608877456088774460875337608753366086804060873954608680416086738660867385608568826085688060855532608528156085552960846158608461576084061960834839608065126082495260820211
- Amount recalled
- 73,002 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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