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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics ReUnion TSA Shoulder system

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  Class 2 Device Recall Stryker Orthopaedics ReUnion TSA Shoulder system see related information
Date Initiated by Firm May 12, 2015
Date Posted August 10, 2015
Recall Status1 Terminated 3 on October 05, 2016
Recall Number Z-2363-2015
Recall Event ID 71445
510(K)Number K103835  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
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
Code Information Catalog #5901-S-4818, Lot MAC7C14.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Paul Jahnke
201-831-5000
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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
Quantity in Commerce 21 units
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = HOWMEDICA OSTEONICS CORP
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