Recall Z-1634-2020— Smith & Nephew, Inc.

Name: FDA recall Z-1634-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-27

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-02-27, terminated 2024-08-02. It names one FDA 510(k) clearance: K121936. Product: NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.. Reason: Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-27
Terminated: 2024-08-02
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K121936 — NAVIOPFSBlue Belt Technologies, Inc.·cleared 2012-11-30

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

NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

Reason for recall

Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

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