| Class 2 Device Recall PressFT2.1 w/ Two 0 (3.5 metric) HiFiSutures | |
Date Initiated by Firm | June 26, 2012 |
Date Posted | October 15, 2012 |
Recall Status1 |
Terminated 3 on October 03, 2014 |
Recall Number | Z-0066-2013 |
Recall Event ID |
63115 |
510(K)Number | K112965 |
Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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Product | "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedures |
Code Information |
Item number NP212 |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
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For Additional Information Contact | 727-392-6464 |
Manufacturer Reason for Recall | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. |
FDA Determined Cause 2 | Process control |
Action | ConMed Linvatec sent an Urgent Medical Device Recall Notification letter on June 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility for the recalled products, segregate them for return to ConMed Linvatec. The customers were also told to return the REPLY FORM to the Regulatory Department at the firm. For questions customers were instructed to call 800-237-0169 or email at Custserv1@linvatec.com.
For questions regarding this recall call 727-392-6464. |
Quantity in Commerce | 879 units for all products in recall event |
Distribution | Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL |
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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510(K) Database | 510(K)s with Product Code = MBI
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