M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Reported: March 16, 2016 Initiated: February 11, 2016 #Z-1046-2016
Product Description
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 9 units
- Distribution
- Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093. Recalled by Zimmer Biomet, Inc.. Units affected: 9 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2016. Severity: Moderate. Recall number: Z-1046-2016.
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