FDA Medical Device Recalls (openFDA)
Telefelx Medical: Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709
- Recall number
- Z-1857-2008
- Recalling firm
- Telefelx 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
- Status
- Terminated
- Initiated
- 2008-05-12
- Posted
- 2008-09-04
- Terminated
- 2012-04-19
- Reason
- The bands are breaking within the sealed packaging or in use prior to the expiration dates.
- 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
- 8492 units
- Distribution
- U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K771187"]
- PMA numbers
- not on file
- Product code
- GDG
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28