Reported Aug 21, 2013 · Terminated
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter…
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. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
- Lot codes and dates
607295286072005960782350608032046081171260889765609094086094302260948237609898416098536661019823610511196103482161140638611780176120769861237374613040056133857061356591638118761400935614316856146333061487660615212676154400561585968616277346170456461735029617724066179458761817713618587016185010361877862619505126199868661972672620102516201807162041751620789636209638762121179621360946214187362158509621804436220339062215390622493726227156662298060
- Amount recalled
- 3,163
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
There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
This product could cause temporary or reversible health problems — stop using it.
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