Recall Z-2774-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2774-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-16

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-07-16. It names one FDA 510(k) clearance: K951987. Product: Tibial knee prosthesis. Reason: Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-07-16
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K951987 — GENESIS II TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc.·cleared 1995-08-22

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

Tibial knee prosthesis

Reason for recall

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

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