FDA Medical Device Recalls (openFDA)
Acera Surgical Inc: Restrata, Part Number RWM1-2X2
- Recall number
- Z-1030-2022
- Recalling firm
- Acera Surgical Inc
- Product
- Restrata, Part Number RWM1-2X2
- Status
- Terminated
- Initiated
- 2022-03-21
- Posted
- not on file
- Terminated
- 2024-08-20
- Reason
- Misprinted expiration date on the shelf-box
- Root cause
- Employee error
- Action
- The 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
- 83 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068
- 510(k) numbers
- ["K170300","K193583"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3012429393
- Firm city
- Woodstock
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28