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
Reported: June 20, 2018 Initiated: May 18, 2018 #Z-2177-2018
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 16
- Distribution
- US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zimmer Biomet, Inc.. Units affected: 16.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2177-2018.
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