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Terminated

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

FDA Recall Z-2363-2015 · Posted 2015-08-10

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWS
Date Initiated2015-05-12
Date Terminated2016-10-05
Product Quantity21 units

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.

Firm Action

Stryker Orthopaedics notified their branches/agencies via email on 5/12/2015 and sent notification letters and product accountability forms to hospital risk management/branches on 7/15/2015 and 7/16/2015

Root Cause

Process control

Distribution Pattern

US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103835REUNION 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. · 2011-05-05

Official Source

View FDA Recall →

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

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