Date Initiated by Firm |
October 24, 2008 |
Date Posted |
November 28, 2008 |
Recall Status1 |
Terminated 3 on September 11, 2009 |
Recall Number |
Z-0415-2009 |
Recall Event ID |
50149 |
Product Classification |
Fiberoptic Retractor - Product Code FDG
|
Product |
Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485.
A fiber optic retractor used in plastic surgery procedures to retract tissue. |
Code Information |
Lot # 042408D08 |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
|
For Additional Information Contact |
904-741-4400
|
Manufacturer Reason for Recall |
Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Consignee was notified by certified mail via an Urgent Medical Device Recall Notice dated 10/24/08, with return receipt. The letter identifies the product and states the issue with the product. The letter required the customer to discontinue use of the item and return it to Biomet Microfixation so that they may rework the instrument. It also asked the customer to notify any hospital personnel responsible for receiving recall notices of this action if the product had been further distributed. The RGA number should be utilized to return the products. The Inventory Reconciliation sheet should be filled out and faxed to 904-741-9425. |
Quantity in Commerce |
3 |
Distribution |
Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI. |
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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