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U.S. Department of Health and Human Services

Class 2 Device Recall PopLok Punch 3.5MM

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  Class 2 Device Recall PopLok Punch 3.5MM see related information
Date Initiated by Firm November 15, 2012
Date Posted February 05, 2013
Recall Status1 Terminated 3 on May 22, 2013
Recall Number Z-0789-2013
Recall Event ID 63823
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm

Orthopedic manual surgical instrument - Bone Punch
Code Information Lot 256058
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 Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
FDA Determined
Cause 2		 Employee error
Action ConMed Linvatech issued a "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to its customers on November 15, 2012 for a recall that was conducted at the end user/distributor level. All recall notifications were sent FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with reason for the recall 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. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169. For questions regarding this recall call 727-399-5205.
Quantity in Commerce 8
Distribution Worldwide Distribution - USA including California and Internationally to Spain 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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