Integra Biotechnical LLC ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
Brand
Integra Biotechnical LLC
Lot Codes / Batch Numbers
Lot number: D632517
Products Sold
Lot number: D632517
Integra Biotechnical LLC is recalling ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625 due to During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
Recommended Action
Per FDA guidance
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.'
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026