Z-1857-2008

Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure...

Name: Z-1857-2008 Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure...
Creator: Telefelx Medical
Published: 2008-05-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2008-05-12 / Terminated / root cause: packaging

FDA source

Telefelx Medical began a recall of Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC... on 2008-05-12. The reason FDA records is "The bands are breaking within the sealed packaging or in use prior to the expiration dates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1857-2008
Status: Terminated
Initiated: 2008-05-12
Posted: 2008-09-04
Terminated: 2012-04-19
Recalling firm: Teleflex Medical
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
Product code: GDG Hook, Surgical, General & Plastic Surgery
Reason for recall: The bands are breaking within the sealed packaging or in use prior to the expiration dates.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: 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.

Product code GDG

K771187Class IDermahook #382-805Edward Weck, Inc. / cleared 1977-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)