| Class 2 Device Recall Bone Plate | |
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
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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
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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 |
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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
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