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U.S. Department of Health and Human Services

Class 3 Device Recall Fredrick's Converse Retractor F/O

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 Class 3 Device Recall Fredrick's Converse Retractor F/Osee related information
Date Initiated by FirmOctober 24, 2008
Date PostedNovember 28, 2008
Recall Status1 Terminated 3 on September 11, 2009
Recall NumberZ-0415-2009
Recall Event ID 50149
Product Classification Fiberoptic Retractor - Product Code FDG
ProductFredrick'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
FEI Number 1032347
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
ActionConsignee 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 Commerce3
DistributionNationwide Distribution --- including states of Chicago, IL and La Crosse, WI.
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.
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