Recall Z-1192-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1192-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-01

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-03-01, terminated 2019-07-18. It names one FDA 510(k) clearance: K060040. Product: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10. Reason: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-01
Terminated: 2019-07-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060040 — ZIMMER M/L TAPER HIP PROSTHESISZimmer, Inc.·cleared 2006-05-12

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

Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10

Reason for recall

Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.

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