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U.S. Department of Health and Human Services

Class 2 Device Recall 6 HOLE REGULAR DOUBLE Y PLATE

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 Class 2 Device Recall 6 HOLE REGULAR DOUBLE Y PLATEsee related information
Date Initiated by FirmJuly 28, 2010
Date PostedMay 27, 2011
Recall Status1 Terminated 3 on June 24, 2011
Recall NumberZ-2385-2011
Recall Event ID 58199
510(K)NumberK953385 
Product Classification Plate, bone - Product Code JEY
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.
Code Information LOTS: 785710, 753120, 693500 and 733600
FEI Number 1032347
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information ContactLaura Sabo
904-741-4400
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).
FDA Determined
Cause 2		Labeling mix-ups
ActionThe 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 Commerce180
DistributionWorldwide 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = JEY
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