Date Initiated by Firm |
November 27, 2018 |
Date Posted |
November 02, 2018 |
Recall Status1 |
Terminated 3 on April 09, 2019 |
Recall Number |
Z-0378-2019 |
Recall Event ID |
81161 |
510(K)Number |
K092096
|
Product Classification |
Dressing, wound, collagen - Product Code KGN
|
Product |
Endoform Dermal Template 2x2, SKU 529312
Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment. |
Code Information |
Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05 |
Recalling Firm/ Manufacturer |
AROA BIOSURGERY 2 Kingsford Smith Place Airport Oaks New Zealand
|
Manufacturer Reason for Recall |
Potential for pouch seal failure
|
FDA Determined Cause 2 |
Employee error |
Action |
The firm sent a Customer Notification letter dated November 27, 2018. The letter identified the affected product, problem and actions to be taken. Customers are encouraged to visually inspect the seals on devices from these lots prior to use with particlar care. Should you observe a comprimised seal, please discard the device and select a new, fully sealed device for use. |
Quantity in Commerce |
8,853 total boxes |
Distribution |
US Nationwide Distribution |
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 = KGN and Original Applicant = MESYNTHES LTD
|