Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
FDA device recall Z-1025-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ascension Orthopedics, Inc
- Reason for recall
- Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
- Action taken
- Recall was initiated via letter included with replacement trays begining in October 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- NEG
- Quantity affected
- 107 trays
- Distribution
- Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada
- Date initiated
- 2003-10-02
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-17
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.