The SternaLock Blu Implant Tray includes plates, screws… recallZ-0843-2012 · Biomet Microfixation, Inc. · initiated Nov 23, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet Microfixation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0843-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 23, 2011
- Posted by the FDA
- Jan 24, 2012
- Recalling firm
- Biomet Microfixation, Inc.
- Quantity
- 109 trays
- Product code
- HRS
- FDA submissions
- K110574
- 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.
Product description
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 (models, lots, serial numbers)
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.
Other devices under the same FDA submission
20 devices cleared under K110574 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STERNALOCK® BLU SYSTEM 73-2414Biomet Microfixation, Inc · PLATE, FIXATION, BONE15 reports
- STERNALOCK® BLU SYSTEM 73-2416Biomet Microfixation, Inc · PLATE, FIXATION, BONE12 reports
- STERNALOCK® BLU SYSTEM 73-2418Biomet Microfixation, Inc · PLATE, FIXATION, BONE11 reports
- STERNALOCK® BLU SYSTEM 73-2412Biomet Microfixation, Inc · PLATE, FIXATION, BONE8 reports
- STERNALOCK® BLU SYSTEM 73-1191Biomet Microfixation, Inc · PLATE, FIXATION, BONE3 reports
- STERNALOCK® BLU SYSTEM 73-2412Biomet Microfixation, Inc · Plate, fixation, bone3 reports
- STERNALOCK® BLU SYSTEM 73-2418Biomet Microfixation, Inc · Plate, fixation, bone3 reports
- STERNALOCK® BLU SYSTEM 73-2410Biomet Microfixation, Inc · PLATE, FIXATION, BONE2 reports
- STERNALOCK® BLU SYSTEM 73-2716Biomet Microfixation, Inc · PLATE, FIXATION, BONE2 reports
- STERNALOCK® BLU SYSTEM 73-2414Biomet Microfixation, Inc · Plate, fixation, bone2 reports
- STERNALOCK® BLU SYSTEM 73-1194Biomet Microfixation, Inc · PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-5412Biomet Microfixation, Inc · PLATE, FIXATION, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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