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U.S. Department of Health and Human Services

Class 2 Device Recall 7.5mm Ti Solid Humeral Nail 230 mm Sterile

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  Class 2 Device Recall 7.5mm Ti Solid Humeral Nail 230 mm Sterile see related information
Date Initiated by Firm February 25, 2010
Date Posted May 07, 2010
Recall Status1 Terminated 3 on October 20, 2014
Recall Number Z-1548-2010
Recall Event ID 55147
510(K)Number K992348  
Product Classification nail, fixation, bone - Product Code JDS
Product 7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S

Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures.
Code Information Catalog/Part number 462.723S. Lot number 6303874 exp 12/2018
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Service
800-479-6329
Manufacturer Reason
for Recall		 potential compatibility issue
FDA Determined
Cause 2		 Device Design
Action The recalling firm, Synthes, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated February 25, 2010, return receipt requested, to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately cease use of the products, examine their inventory for the part/lot combinations and remove the recalled devices from their shelves, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number and return the recalled product with the letter; however, if the customers do not have the identified product , they should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at lewis.lynne@synthes.com. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.
Quantity in Commerce 1 unit
Distribution Nationwide distribution: LA, MA, ME, NC, PA and VA.
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 = JDS and Original Applicant = SYNTHES (USA)
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