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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Plate

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  Class 2 Device Recall Bone Plate see related information
Date Initiated by Firm April 26, 2010
Date Posted March 23, 2012
Recall Status1 Terminated 3 on April 18, 2012
Recall Number Z-1286-2012
Recall Event ID 61207
510(K)Number K953385  
Product Classification Plate, bone - Product Code JEY
Product Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***"

Product Usage - CTS Usage:
Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Code Information Lot 193690
Recalling Firm/
Manufacturer		 Biomet Microfixation, LLC
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-4400
Manufacturer Reason
for Recall		 On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.
FDA Determined
Cause 2		 Error in labeling
Action Biomet Microfixation, LLC sent an Urgent Medical Device Safety Alert letter dated April 21, 2010 to all consignees affected. Each consignee was notified by E-mail, letter or telephone call the week of April 26, 2010. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX it to the attention of the Global Complaint Coordinator at 904-741-9425. If the affected product have been further distribute, consignees are instructed to notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field action notices. For questions contact Christy Cain at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
Quantity in Commerce 23
Distribution USA Nationwide Distribution including the states of: California and Texas.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JEY and Original Applicant = WALTER LORENZ SURGICAL, INC.
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