Recall Z-2363-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2363-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-12

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-05-12, terminated 2016-10-05. It names one FDA 510(k) clearance: K103835. Product: ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland. Reason: A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-05-12
Terminated: 2016-10-05
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K103835 — REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM NHowmedica Osteonics Corp.·cleared 2011-05-05

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

ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

Reason for recall

A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

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