Reported Mar 15, 2017 · Terminated
RSP Impaction Fixture
Encore Medical, LP
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: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- RSP Impaction Fixture
- Lot codes and dates
109931L01109931L02115670L15115670L16128092L08128092L09137917L16167829L0652258L0152258L01A67428L0176386L0176386L0281722L0181722L02
- Amount recalled
- 626 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
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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