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Class 2 Device Recall 6 HOLE REGULAR DOUBLE Y PLATE |
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Date Initiated by Firm |
July 28, 2010 |
Date Posted |
May 27, 2011 |
Recall Status1 |
Terminated 3 on June 24, 2011 |
Recall Number |
Z-2385-2011 |
Recall Event ID |
58199 |
510(K)Number |
K953385
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Product Classification |
Plate, bone - Product Code JEY
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Product |
***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT***
This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognathic procedures in the midface.
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Code Information |
LOTS: 785710, 753120, 693500 and 733600 |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
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For Additional Information Contact |
Laura Sabo 904-741-4400
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Manufacturer Reason for Recall |
Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y).
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The firm, Biomet Microfixation, sent an "URGENT MEDICAL SAFETY ALERT NOTICE" letter dated July 28, 2010 to its customers/distributors. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their stock and ensure that the plates were properly distributed into their trays and that they have the sufficient quantity of plates that they need. In addition, they were instructed to complete and return the attached Inventory Reconciliation form via fax to: Attn: Customer Relations Specialist at 904-741-9425 and notify the recipient of this notice, if they have further distributed the product.
If you have any questions, please contact the Customer Relations Specialist at 800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET. |
Quantity in Commerce |
180 |
Distribution |
Worldwide distribution: USA (nationwide) including states of: FL, IN, KY, MT, NC, NE, NY, OH, TX, VA, and WI; and countries including: Argentina, Canada, Colombia, Czech Republic, Japan, Korea, Mexico, Norway, South Africa, Spain and Turkey. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JEY and Original Applicant = WALTER LORENZ SURGICAL, INC.
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