FDA Medical Device Recalls (openFDA)
Teleflex Medical: Weck, DermaHook (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.
- Recall number
- Z-0678-2012
- Recalling firm
- Teleflex Medical
- Product
- Weck, DermaHook (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.
- Status
- Terminated
- Initiated
- 2011-12-06
- Posted
- 2012-01-11
- Terminated
- 2014-05-20
- Reason
- Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.
- Root cause
- Under Investigation by firm
- Action
- The firm, Teleflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 6, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine any products with the listed catalog and lot numbers; communicate this recall to any of their customers who have received the product; have their customers return the affected product together with a completed Recall Acknowledgement Form to Teleflex Medical, if an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990; complete and return the Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customers Service even if they and their customers have no affected stock. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- to be obtained
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog number: 382805, Lot numbers: 01A1100470, 01A1100374, 01A1100517, 01A1100519, 01B1100006, 01B1100131, 01B1100159, 01B1100275, 01E1000026, 01F1000586, 01G1000137, 01G1000139, 01G1000251, 01G1000326, 01H1000271, 01H1000296, 01J1000267, 01J1000298, 01K1000005, 01K1000051, 01K1000181, 01K1000334, 01L1000282, 01L1000283, 01L1000292, 01M1000008, 01M1000144, 01M1000198, 01M1000199 and 01M1000200.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDG
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- 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