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U.S. Department of Health and Human Services

Class 2 Device Recall Weck DermaHook

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  Class 2 Device Recall Weck DermaHook see related information
Date Initiated by Firm May 12, 2008
Date Posted September 04, 2008
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-1857-2008
Recall Event ID 48135
510(K)Number K771187  
Product Classification Hook, Surgical, General & Plastic Surgery - Product Code GDG
Product Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709
Code Information Catalog #382805, All manufacturing dates from 4/1/2006 through 3/19/2008; Lot numbers: 01A0800086, 01A0800168, 01A0822216, 01A0800323, 01L0700096, 01L0700257, 1996021, 2230335, 2614566, T1206008, T1206537, T1209084, T1209085, T1209525, T1211001, T1211685, T1212658, T1223079, T1226004, T1227679, T1229934, T1231416, T1233264, T1234305, T1236177, T1239174, T1242796,T1243832, T1243833, T1243834, T1247442, T1250478, T1251531, T1252452, T1254316, T1255368, T1256381, T1257718, T1258301, T1266798, T1267798, T1268854, T1269783, T1270679, T1271622, T1277206, T1277284, T1279907.
Recalling Firm/
Manufacturer		 Telefelx Medical
2917 Weck Drive
Durham NC 27709
For Additional Information Contact Michael Taggart
919-433-4816
Manufacturer Reason
for Recall		 The bands are breaking within the sealed packaging or in use prior to the expiration dates.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Consignees were notified by letter via UPS next day, on/about 05/12/2008. They were instructed to return all affected product or acknowledge that the product no longer exists. They were further instructed to forward the letter to if they have further distributed the affected lots into institutional settings or to homecare patients and retrieve relevant product from those locations. If you require additional information or clarification regarding this matter, please contact Jackie Warner at 1-800-334-9751, ext. 4973.
Quantity in Commerce 8492 units
Distribution U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands
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 = GDG and Original Applicant = EDWARD WECK, INC.
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