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U.S. Department of Health and Human Services

Class 1 Device Recall PROFEMUR PLUS CoCr MODULAR NECK PHAC1254

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  Class 1 Device Recall PROFEMUR PLUS CoCr MODULAR NECK PHAC1254 see related information
Date Initiated by Firm August 04, 2015
Date Posted September 28, 2015
Recall Status1 Terminated 3 on August 17, 2018
Recall Number Z-2743-2015
Recall Event ID 71925
510(K)Number K100866  K091423  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
Product PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper.
Orthopedic hip prosthesis component.
Code Information All lot codes
Recalling Firm/
Manufacturer		 MicroPort Orthopedics, Inc.
5677 Airline Rd
Arlington TN 38002-9501
Manufacturer Reason
for Recall		 Unexpected rate of postoperative fractures resulting in the need for revision surgery.
FDA Determined
Cause 2		 Device Design
Action Micro Port Orthopedics sent a Voluntary Device Product Recall letter dated August 7, 2015, via Fed Ex to all affected customers. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to locate and return effected product immediately. Customers with questions were instructed to call 1-866-872-0211. Customers were also asked to return the enclosed form immediately even if they do not have any affected product to return.
Quantity in Commerce 10,489 units
Distribution Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
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 = MBL and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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