Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
- Company
- Ascension Orthopedics, Inc
- Recall Initiated
- October 2, 2003
- Posted
- July 20, 2004
- Terminated
- June 17, 2004
- Recall Number
- Z-1025-04
- Quantity
- 107 trays
- Firm Location
- Austin, TX
Reason for Recall
Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
Distribution
Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada
Lot / Code Info
All trays remaining in the marketplace are subject to the recall.
Root Cause
Other
Action Taken
Recall was initiated via letter included with replacement trays begining in October 2003.
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