Z-0714-2007

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

Name: Z-0714-2007 ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
Creator: Integra Biotechnical LLC
Published: 2007-02-01
License: https://open.fda.gov/license/

Amphenol Critical Medical Technologies, LLC / initiated 2007-02-01 / Terminated / root cause: sterility

FDA source

Integra Biotechnical LLC began a recall of ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625 on 2007-02-01. The reason FDA records is "During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0714-2007
Status: Terminated
Initiated: 2007-02-01
Posted: 2007-04-04
Terminated: 2012-08-03
Recalling firm: Amphenol Critical Medical Technologies, LLC
Product: ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: sterility
FDA root cause: Other
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.'
Quantity in commerce: 1769
Distribution: Nationwide
Product codes and lots: Lot number: D632517

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)