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Terminated

ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625

FDA Recall Z-0714-2007 · Posted 2007-04-04

Recalling FirmIntegra Biotechnical LLC
Recall StatusTerminated
Product CodeFRO
Date Initiated2007-02-01
Date Terminated2012-08-03
Product Quantity1769

Reason for Recall

During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.

Firm Action

An email and/or fax recall notification was sent starting on 02/1/2007 by Arthrex, Inc. (the Primary Distributor) . A product recall notice in the form of a letter was mailed via US Postal Certified Mail, return receipt requested by Arthrex, Inc. to all of the Distributor''s customers starting on 02/1/2007, including those who have not ordered or received the Recalled Product. Customers were asked to 'segregate and protect the product from shipment, and return all unused products to Arthrex, Inc.'

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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