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.
FDA Recall Z-0691-2020 · Posted None
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Recalling FirmIntegra Lifesciences Sales Llc
Recall StatusTerminated
Product CodeKYJ
Date Initiated2019-11-04
Date Terminated2020-05-05
Product Quantity9 units
Reason for Recall
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Firm 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 to Friday 8:00 AM 8:00 PM EST
USA: 1-800-654-2873: email: [email protected]
Outside USA: 781-565-1401
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide distribution in the state of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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