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U.S. Department of Health and Human Services

Class 2 Device Recall PROFEMUR(R) R RASP HANDLE

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  Class 2 Device Recall PROFEMUR(R) R RASP HANDLE see related information
Date Initiated by Firm November 17, 2016
Date Posted January 03, 2017
Recall Status1 Terminated 3 on August 18, 2018
Recall Number Z-0943-2017
Recall Event ID 75888
510(K)Number K012091  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN
Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
Code Information Lot Number US100122
Recalling Firm/
Manufacturer
MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Kyle Nevill
901-867-4318
Manufacturer Reason
for Recall
The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
FDA Determined
Cause 2
Process control
Action MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to PostMarket@ortho.microport.com. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.
Quantity in Commerce 20 units
Distribution Worldwide Distribution to Spain, China, and Italy
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 = LZO and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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