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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOFUSE(R) Fusion Rods

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 Class 2 Recall
ENDOFUSE(R) Fusion Rods
see related information
Date Posted June 17, 2011
Recall Status1 Terminated on December 27, 2012
Recall Number Z-2589-2011
Recall Event ID 58717
Premarket Notification
510(K) Number
K051309 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
Code Information Lot Number 088605355, Reference #500005950
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002-9501
For Additional Information Contact Cathy Park
901-867-4324
Manufacturer Reason
for Recall
Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401. If you have any questions regarding this matter, please contact 800-874-5630.
Quantity in Commerce 65
Distribution Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, ID, IN, IL, LA, MI, MN, MO, NC, NE, NH, NY, OH, PA, SC, TN, TX, VA, VT, WA, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = REILEY ORTHOPAEDICS, INC.
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