FDA Medical Device Recalls (openFDA)
Integra Biotechnical LLC: ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
- Recall number
- Z-0714-2007
- Recalling firm
- Integra Biotechnical LLC
- Product
- ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
- Status
- Terminated
- Initiated
- 2007-02-01
- Posted
- 2007-04-04
- Terminated
- 2012-08-03
- Reason
- During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
- 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
- 1769
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot number: D632517
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1000519289
- Firm city
- Vista
- Firm state
- CA
- 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