Recall Z-3000-2020— ArthroCare Corporation

Name: FDA recall Z-3000-2020
Creator: U.S. Food and Drug Administration
Published: 2019-02-21

Class II · Terminated

Class II FDA medical device recall by ArthroCare Corporation, initiated 2019-02-21, terminated 2022-08-17. It names one FDA 510(k) clearance: K123268. Product: Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971. Reason: The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use..

Recalling firm: ArthroCare Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-02-21
Terminated: 2022-08-17
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K123268 — SMARTSTITCH PERFECTPASSER SYSTEMArthocare Corporation·cleared 2012-11-07

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

Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

Reason for recall

The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.

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