Recall Z-0691-2020 ยท KYJ Prosthesis, Finger, Constrained, Polymer
Integra Lifesciences Sales Llc
Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
| Date | Nov 4, 2019 |
| Status | Terminated |
| Reason | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant |
| Root cause | Labeling mix-ups |
| Action | Integra notified by letter consignee via courier service, facsimile or email between November 4th and 6th, 2019, advising reason for recall, health risk and action to take: confirm that the device was actually implanted as part of the above-referenced surgery and, if so, please confirm the date of that surgery. 2. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday |
| Quantity | 9 units |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082231 | ASCENSION SILICONE PIP Ascension Orthopedics, Inc., Jan 12, 2009 |