FDA Medical Device Recalls (openFDA)
Ascension Orthopedics, Inc: Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
- Recall number
- Z-1025-04
- Recalling firm
- Ascension Orthopedics, Inc
- Product
- Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
- Status
- Terminated
- Initiated
- 2003-10-02
- Posted
- 2004-07-20
- Terminated
- 2004-06-17
- Reason
- Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
- Root cause
- Other
- Action
- Recall was initiated via letter included with replacement trays begining in October 2003.
- Quantity
- 107 trays
- Distribution
- Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada
- Lot, serial or model codes
- All trays remaining in the marketplace are subject to the recall.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEG
- Firm FEI
- 3002788818
- Firm city
- Austin
- Firm state
- TX
- 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