Recall Z-1229-2020— Taewoong Medical Co., Ltd.

Name: FDA recall Z-1229-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-18

Class II · Terminated

Class II FDA medical device recall by Taewoong Medical Co., Ltd., initiated 2019-10-18, terminated 2021-10-15. It names 3 FDA 510(k) clearances: K123205, K113551, K080782. Product: Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F. Reason: Misprinted IFUs shipped with esophageal stents.

Recalling firm: Taewoong Medical Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2019-10-18
Terminated: 2021-10-15
Firm location: Gyeonggi-Do, Korea (the Republic of)

510(k) clearances named in this recall

3 on FDA's record

K123205 — ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd.·cleared 2013-10-09
K113551 — ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd.·cleared 2012-02-14
K080782 — NITI-S ESOPHAGEAL STENTTaewoong Medical Co., Ltd.·cleared 2009-01-30

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

Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F

Reason for recall

Misprinted IFUs shipped with esophageal stents

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