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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Integra Lifesciences Sales Llc
Lot Codes / Batch Numbers
Lot Number: Lot 192715T
Products Sold
Lot Number: Lot 192715T
Integra Lifesciences Sales Llc is recalling Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension due to Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Recommended Action
Per FDA guidance
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 to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026