Recall Z-0196-2019— Medacta Usa Inc

Name: FDA recall Z-0196-2019
Creator: U.S. Food and Drug Administration
Published: 2017-11-15

Class II · Terminated

Class II FDA medical device recall by Medacta Usa Inc, initiated 2017-11-15, terminated 2019-03-29. It names one FDA 510(k) clearance: K170845. Product: Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.. Reason: Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-15
Terminated: 2019-03-29
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K170845 — MiniMAXMedacta International S.A.·cleared 2017-08-08

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

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Reason for recall

Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

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