FDA Device recall Z-2177-2018
Biomet Modular Primary Tibial Tray Implants
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Biomet Modular Primary Tibial Tray Implants by Zimmer Biomet, citing 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 siz….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2177-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-18 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | FL, GA, IN, MA, NM, UT, WI |
Product
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
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.
Identifiers
| code_info | Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2177-2018%22
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