Reported May 15, 2013 · Terminated
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a…
Synthes USA HQ, 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: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes Radial Head ProsthesisTrial
- Radial Head Elbow joint prosthesisSynthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly
- Lot codes and dates
- All Lots of Part Numbers
03.402.01803.402.02003.402.02203.402.02403.402.02603.402.02803.402.21803.402.22003.402.22203.402.22403.402.22603.402.22803.402.41803.402.42003.402.42203.402.42403.402.42603.402.42803.402.61803.402.62003.402.62203.402.62403.402.626and 03.402.628
- All Lots of Part Numbers
- Amount recalled
- 417
Where it was sold
Why it was recalled
The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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