Recall Z-1524-2010 ยท NEG Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
Ascension Orthopedics, Inc
Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
| Date | May 4, 2010 (initiated Jun 17, 2009) |
| Status | Terminated |
| Reason | Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant. |
| Root cause | Device Design |
| Action | Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement. For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549. |
| Quantity | 129 units (64 US, 65 OUS) |
| Distribution | Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.