ClearanceBrief
Recall Z-1030-2022 · FRO Dressing, Wound, Drug

Acera Surgical Inc

Restrata, Part Number RWM1-2X2

DateMar 21, 2022
StatusTerminated
ReasonMisprinted expiration date on the shelf-box
Root causeEmployee 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.
Quantity83 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K170300Restrata Wound Matrix
Acera Surgical, Inc., Apr 26, 2017
K193583Restrata®
Acera Surgical, Inc., Sep 25, 2020