|
Class 2 Device Recall Weck DermaHook |
|
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.
|
|
|
|