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U.S. Department of Health and Human Services

Class 2 Device Recall Dermabond "Prineo" System

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  Class 2 Device Recall Dermabond "Prineo" System see related information
Date Initiated by Firm November 27, 2017
Create Date March 21, 2018
Recall Status1 Terminated 3 on April 30, 2019
Recall Number Z-1147-2018
Recall Event ID 79355
510(K)Number K133864  
Product Classification Prosthesis, hip, semi-constrained, polyurethane acetabular bearing surface, cemented or uncemented - Product Code OMO
Product DERMABOND" PRINEO" Skin Closure System

Product Usage:
DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive
Code Information LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact Tom Morris
908-218-0707
Manufacturer Reason
for Recall		 Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
FDA Determined
Cause 2		 Component change control
Action Ethicon sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated November 2017 to customers titled: "DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM (22 CM)". The letter identified the affected product, problem and action to be taken. The letter instructed customers to do not use or distribute any product which is subject to recall. Customers are asked to examine inventory, quarantine products that are subject to recall and contact the firm for return of product. Also, post the recall letter in a visible location at facility. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
Quantity in Commerce 20,090 eaches (10,545 units)
Distribution US Nationwide Distribution
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 = OMO and Original Applicant = ETHICON, INC.
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