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U.S. Department of Health and Human Services

Class 2 Device Recall XChange Wall Mesh Small (6Petal)

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  Class 2 Device Recall XChange Wall Mesh Small (6Petal) see related information
Date Initiated by Firm October 03, 2019
Create Date November 22, 2019
Recall Status1 Open3, Classified
Recall Number Z-0514-2020
Recall Event ID 84148
510(K)Number K121308  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint
REF 0942-8-025
Code Information Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)
Recalling Firm/
Manufacturer
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Rehad Gaffoor
954-6280808
Manufacturer Reason
for Recall
Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
FDA Determined
Cause 2
Employee error
Action Stryker issued An Urgent Field Safety Notice (FSN), PFA 2197654, was issued to all affected OUS consignees at country level on October 03, 2019. Action to take: Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Complete customer response form and return the form and any affected devices to the following address. (Please complete this form regardless of whether your organization has product to return. This will preclude the need for Stryker to send any reminder notice.) ATTN: David Nihill, Limerick Finished Goods Centre C/O Flextronics Global Services Ireland Unit 1 Raheen Business Park Raheen, Limerick.
Quantity in Commerce 40 units
Distribution Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = HOWMEDICA OSTEONICS CORP
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