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U.S. Department of Health and Human Services

Class 2 Device Recall Deknalok

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  Class 2 Device Recall Deknalok see related information
Date Initiated by Firm March 11, 2014
Date Posted May 01, 2014
Recall Status1 Terminated 3 on March 29, 2016
Recall Number Z-1535-2014
Recall Event ID 67973
510(K)Number K992088  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
Code Information Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Quantity in Commerce 7,380 ea (total)
Distribution Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
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.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
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