FDAFDA · Food and drugs·Recall number Z-1046-2016
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Published March 16, 2016 · Recall initiated: February 11, 2016
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
Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
- Lot
- Item: 00-7711-012-20, Lot: 62937093
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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