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.
This recall has been terminated (originally issued January 24, 2012).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- November 23, 2011
- Posted
- January 24, 2012
- Terminated
- April 3, 2012
- Recall Number
- Z-0843-2012
- Quantity
- 109 trays
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.