Z-2177-2018 Class II Terminated
FDA device recall Z-2177-2018 was initiated by Zimmer Biomet, Inc. on May 18, 2018 and is designated Class II. Reason for recall: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component… The recall status is terminated (terminated Mar 31, 2020). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- May 18, 2018
- Termination Date
- Mar 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
Reason for Recall
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
Distribution Pattern
US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico
Code Information
Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2177-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026