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U.S. Department of Health and Human Services

Class 2 Device Recall SternaLock Blu Implant Tray

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 Class 2 Recall
SternaLock Blu Implant Tray
see related information
Date Posted January 24, 2012
Recall Status1 Terminated on April 03, 2012
Recall Number Z-0843-2012
Recall Event ID 60682
Premarket Notification
510(K) Number
K110574 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer containers: Silver Instrument Tray, with a White rack, and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1301***STERNALOCK IMPLANT TRAY***256X 125.5 MM (10.080 x 4.940 ") (LXW)***Polypropylene, Aluminum, Stainless Steel***" A 3" tall container, with blue rubber handles, and a Power Driver warning on the container lid. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1302***STERNALOCK BLU IMPLANT TRAY SEMIMODULAR***256X 125.5 MM (10.080 x 4.940 ") (LXW)Polypropylene, Aluminum, Stainless Steel***" A 5" tall container, with a wide metal latch to secure the lid, and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1300***STERNALOCK BLU IMPLANT SEMI MODULAR TRAY***228.6X 128.8MM (9.00 x 5.07 ") (LXW)Polypropylene, Aluminum, Radel***". The Biomet Microfixation SternaLock Blu System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. There SternaLock instrument tray has been designed specifically to store the implants for this system.
Code Information Model Number 73-1300, Lot numbers: 032211, 042911, 100611. Model Number 73-1301, Lot numbers: 249640, 280130, 280131, 312560, 031411. Model Number 73-1302, Lot number: 011411.
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville, Florida 32218-2480
Consumer Instructions No consumer action necessary
For Additional Information Contact Rachel Osbeck
904-741-4400 Ext. 9448
Manufacturer Reason
for Recall
Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the screw measuring area inside the SternaLock Blu Implant Tray, could lead to the improper selection of a screw 2mm longer than needed.
FDA Determined
Cause 2
DESIGN: Device Design
Action Biomet Microfixation, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides a "Recommended Technique" to be followed to correct the problem until replacement trays are available. Contact the Quality Improvement Manager at 1-800-874-7711 for questions regarding this notice.
Quantity in Commerce 109 trays
Distribution Worldwide Distribution-- USA (nationwide) including the states of AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KY, MD, MO, MS, NC, NE, NJ, NY, OK, OR, PA, SC, TN, TX, WA, and WI. and countries of Argentina, Australia, Canada, Denmark, Finland, Germany, South Africa, and Spain.
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 = HRS and Original Applicant = BIOMET MICROFIXATION, INC.
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