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U.S. Department of Health and Human Services

Class 2 Device Recall 6hole Pubic Symphysis plate

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  Class 2 Device Recall 6hole Pubic Symphysis plate see related information
Date Initiated by Firm January 19, 2017
Date Posted February 14, 2017
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-1199-2017
Recall Event ID 76332
510(K)Number K122538  
Product Classification Plate, fixation, bone - Product Code HRS
Product 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with
3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate.

The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Code Information Lot number: 383813
Recalling Firm/
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information Contact Business Services or Agent Inventory
503-627-9957 Ext. 4
Manufacturer Reason
for Recall
The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135  Ti alloy) and was distributed.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Acumed sent an Urgent Medical Device Recall letter dated January 16, 2017, to all affected customers on January 19, 2017. Consignees were instructed to follow special instructions and send survey to RecallNotification@acumed.net. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at BusinessServices@acumed.net or via phone 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada) have to obtain a Return Material Authorization (RMA) number.
Quantity in Commerce 15 units
Distribution Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, 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 = HRS and Original Applicant = ACUMED LLC