Recall Z-2177-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-2177-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-18

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-05-18, terminated 2020-03-31. It names 4 FDA 510(k) clearances: K171054, K142933, K010212 and 1 more. 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-18
Terminated: 2020-03-31
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

4 on FDA's record

K171054 — Biomet Knee Joint Replacement ProsthesesBiomet, Inc.·cleared 2017-07-28
K142933 — Biomet Tibial traysBiomet, Inc.·cleared 2014-12-23
K010212 — OFFSET TIBIAL TRAYBiomet, Inc.·cleared 2001-02-14
K915132 — MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEMBiomet, Inc.·cleared 1992-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.