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Terminated

Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only.

FDA Recall Z-1856-2008 · Posted 2008-09-04

Recalling FirmTelefelx Medical
Recall StatusTerminated
Product CodeGDG
Date Initiated2008-05-12
Date Terminated2012-04-19
Product Quantity5763 units

Reason for Recall

The bands are breaking within the sealed packaging or in use prior to the expiration dates.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K771187DERMAHOOK #382-805Edward Weck, Inc. · 1977-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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