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U.S. Department of Health and Human Services

Class 2 Device Recall Restrata Wound Dressing

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 Class 2 Device Recall Restrata Wound Dressingsee related information
Date Initiated by FirmMarch 21, 2022
Create DateMay 02, 2022
Recall Status1 Terminated 3 on August 20, 2024
Recall NumberZ-1030-2022
Recall Event ID 89919
510(K)NumberK170300 K193583 
Product Classification Dressing, wound, drug - Product Code FRO
ProductRestrata, Part Number RWM1-2X2
Code Information Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068
FEI Number 3012429393
Recalling Firm/
Manufacturer		 Acera Surgical Inc
7842 Hickory Flat Hwy Ste B
Woodstock GA 30188-6579
For Additional Information ContactTam¿s Kov¿cs
844-879-2237
Manufacturer Reason
for Recall		Misprinted expiration date on the shelf-box
FDA Determined
Cause 2		Employee error
ActionThe firm initiated the recall by letter, either hand delivered or via certified mail, beginning on 03/21/2022. The notice explained the problem and requested return of the product.
Quantity in Commerce83 units
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRO
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