Recall Z-1030-2022— Acera Surgical Inc

Name: FDA recall Z-1030-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-21

Class II · Terminated

Class II FDA medical device recall by Acera Surgical Inc, initiated 2022-03-21, terminated 2024-08-20. It names 2 FDA 510(k) clearances: K193583, K170300. Product: Restrata, Part Number RWM1-2X2. Reason: Misprinted expiration date on the shelf-box.

Recalling firm: Acera Surgical Inc
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Terminated: 2024-08-20
Firm location: Woodstock, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K193583 — Restrata®Acera Surgical, Inc.·cleared 2020-09-25
K170300 — Restrata Wound MatrixAcera Surgical, Inc.·cleared 2017-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Restrata, Part Number RWM1-2X2

Reason for recall

Misprinted expiration date on the shelf-box

Data sourced from openFDA. This site is unofficial and independent of the FDA.