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U.S. Department of Health and Human Services

Class 2 Device Recall Ascension Silicone PIPSilicone

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  Class 2 Device Recall Ascension Silicone PIPSilicone see related information
Date Initiated by Firm November 04, 2019
Create Date December 16, 2019
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-0691-2020
Recall Event ID 84320
510(K)Number K082231  
Product Classification Prosthesis, finger, constrained, polymer - Product Code KYJ
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.
Code Information Lot Number: Lot 192715T
Recalling Firm/
Manufacturer		 Integra Lifesciences Sales Llc
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-309-3966
Manufacturer 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
FDA Determined
Cause 2		 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 to Friday 8:00 AM  8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401
Quantity in Commerce 9 units
Distribution US Nationwide distribution in the state of CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KYJ and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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