Z-1798-2015 Class II Terminated
FDA device recall Z-1798-2015 was initiated by Biomet, Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle… The recall status is terminated (terminated Mar 22, 2016). Affected quantity: 27.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 24, 2015
- Initiation Date
- Apr 22, 2015
- Termination Date
- Mar 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27
Product Description
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Reason for Recall
The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.
Distribution Pattern
Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
Code Information
Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1798-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026