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Terminated

Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall.

FDA Recall Z-1163-2010 · Posted 2010-03-18

Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeKOG
Date Initiated2010-02-08
Date Terminated2010-05-25
Product Quantity45

Reason for Recall

weak weld seams

Firm Action

The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923982OLYMPUS OES LAPAROSCOPY SYSTEMOlympus Corp. · 1993-03-15K790071ENDOSCOPE AND ACCESSORIESOlympus Corp. · 1979-04-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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