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U.S. Department of Health and Human Services

Class 2 Device Recall PopLok Punch

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  Class 2 Device Recall PopLok Punch see related information
Date Initiated by Firm July 06, 2012
Date Posted August 06, 2012
Recall Status1 Terminated 3 on November 21, 2013
Recall Number Z-2151-2012
Recall Event ID 62665
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product PopLok Punch labeled in part:
"PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***"

Intended Use: Bone Punch.
Code Information Lot 318455
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-399-5205
Manufacturer Reason
for Recall		 ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.
FDA Determined
Cause 2		 Process change control
Action The recall is being conducted to the end user level. ConMed Linvatec Urgent Medical Device Recall Notifications were sent by FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with the reason for the recall and health risk. All accounts were asked to immediately check their facility for the affected product, stop using any of the product with specified lot number, and to segregate the product. The letter also asked customers to return all affected product to ConMed Linvatec and respond using a Reply Form, even if there is no affected product available. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169.
Quantity in Commerce 2
Distribution Worldwide Distribution -- US and Korea.
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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