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Class 2 Device Recall PERMAHAND Silk Suture |
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Date Initiated by Firm |
December 18, 2018 |
Create Date |
January 16, 2019 |
Recall Status1 |
Terminated 3 on May 29, 2020 |
Recall Number |
Z-0747-2019 |
Recall Event ID |
81820 |
510(K)Number |
K946173
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Product Classification |
Suture, nonabsorbable, silk - Product Code GAP
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Product |
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T
Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. |
Code Information |
Product Lot MEH906 |
Recalling Firm/ Manufacturer |
Ethicon, Inc. Us Highway 22 West Somerville NJ 08876
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Manufacturer Reason for Recall |
The sutures inside the packaging are not the same size or type as indicated on the label.
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FDA Determined Cause 2 |
Packaging process control |
Action |
Ethicon sent an Urgent Medical Device Recall notification letters to customers on 12/18/18. The letter identified the affected product, problem and actions to be taken. For questions contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). |
Quantity in Commerce |
840 |
Distribution |
The products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = GAP and Original Applicant = ETHICON, INC.
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