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U.S. Department of Health and Human Services

Class 2 Device Recall Optigun Ratchet

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  Class 2 Device Recall Optigun Ratchet see related information
Date Initiated by Firm May 14, 2015
Date Posted June 10, 2015
Recall Status1 Terminated 3 on October 27, 2015
Recall Number Z-1744-2015
Recall Event ID 71365
Product Classification Dispenser, cement - Product Code KIH
Product The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
Code Information Catalog number: 419500 Lot number: 0101296012
Recalling Firm/
Manufacturer		 BIOMET FRANCE S.A.R.L.
plateau de lautagne
valence cedex 9
Valence Cedex 9 France
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.
Quantity in Commerce 3
Distribution Nationwide distribution to MD only
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.
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