The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant
FDA device recall Z-0843-2012 · posted 2012-01-24 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 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
- Date initiated
- 2011-11-23
- Date posted
- 2012-01-24
- Date terminated
- 2012-04-03
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM (K110574) | Biomet Microfixation, Inc. | 2011-05-18 |