Reported May 2, 2018 · Terminated
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder…
Synthes, 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, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
- Lot codes and dates
09-679310-263710-507012-270714-108515-8949
- Amount recalled
- 31
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 a potential for the connection screw of the stem extractor to break.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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