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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm August 15, 2014
Date Posted May 19, 2015
Recall Status1 Terminated 3 on January 05, 2018
Recall Number Z-1633-2015
Recall Event ID 70994
510(K)Number K102019  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.

Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.
Code Information Ref #:Lot Number - 5096-4615:MMR8M8; 5096-4615:MMRLYD; 5096-4615:MNAYT7; 5096-5015:MMPO6K; 5096-5015:MMRWOJ; 5096-5015:MNADVA; 5096-5815:MNA40L; 5096-5820:MMR6HX; 5096-5825:MMRLD7; 5096-6225:MMPWO5; 5096-6225:MMRM2Y; 5096-6625:MMNM07
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Paul Jahnke
Manufacturer Reason
for Recall
The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Stryker Orthopaedics, notified their Branches/Agencies via email on 8/15/2014 and sent an "Urgent Product Recall" letter dated 8/15/2014 with a Product Recall Acknowledgement Forms to their Branches/Agencies and consignees. The letter describes the product, issue, potential hazards and actions to be taken. The consignees were instructed to complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah NJ 07430. If you have any questions, feel free to contact Sr. Regulatory Compliance Specialist to 201-831-5826.
Quantity in Commerce 1,147 in total
Distribution Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
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 = HOWMEDICA OSTEONICS