Reported Sep 6, 2017 · Terminated
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF…
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?
- MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN
- Catalog Numbers
REF S-200956 - 5mm PINSIZE 46 REF S-200957 - 5mm PINSIZE 50 REF S-200958 - 5mm PINSIZE 58
- Lot codes and dates
Catalog numberLot Number S-200956535U1000 S-200957536U1000 S-200958537U1000
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
This product could cause temporary or reversible health problems — stop using it.
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