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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Trident Constrained Liner Impactors

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  Class 2 Device Recall Stryker Trident Constrained Liner Impactors see related information
Date Initiated by Firm June 03, 2016
Create Date July 25, 2016
Recall Status1 Terminated 3 on August 01, 2018
Recall Number Z-2281-2016
Recall Event ID 74500
510(K)Number K151264  
Product Classification Orthopedic manual surgical instrument - Product Code LPH
Product Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile
Catalog Numbers 2199-2022, 2199-2028 and 2199-2032.
For use in total hip arthroplasty.
Code Information Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
Manufacturer Reason
for Recall		 Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
FDA Determined
Cause 2		 Process design
Action Stryker notified its branches/agencies of this recall by e-mail on May 26, 2016. They were asked to quarantine the affected devices. Stryker sent a recall letter and business reply form dated June 3, 2016 to their affected customers via UPS. Stericycle will be handling the returns.
Quantity in Commerce 1,864 units
Distribution Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.
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 = LPH and Original Applicant = STRYKER ORTHOPAEDICS
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