FDAFDA · Food and drugs·Recall number Z-1412-2017
Turon Impaction Fixture
Published March 15, 2017 · Recall initiated: February 9, 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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
- Lot
- 101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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