FDAFDA · Food and drugs·Recall number Z-3102-2017
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Published September 6, 2017 · Recall initiated: August 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- OH, VA
- Lot
- Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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