Z-1046-2016 Class II Terminated
FDA device recall Z-1046-2016 was initiated by Zimmer Biomet, Inc. on Feb 11, 2016 and is designated Class II. 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… The recall status is terminated (terminated Dec 1, 2016). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2016
- Initiation Date
- Feb 11, 2016
- Termination Date
- Dec 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
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.
Distribution Pattern
Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
Code Information
Item: 00-7711-012-20, Lot: 62937093
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1046-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026