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
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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
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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
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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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