Recall Z-1025-04 ยท NEG Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
Ascension Orthopedics, Inc
Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
| Date | Jul 20, 2004 (initiated Oct 2, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.