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Terminated

Restrata, Part Number RWM1-2X2

FDA Recall Z-1030-2022 · Posted None

Recalling FirmAcera Surgical Inc
Recall StatusTerminated
Product CodeFRO
Date Initiated2022-03-21
Date Terminated2024-08-20
Product Quantity83 units

Reason for Recall

Misprinted expiration date on the shelf-box

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193583Restrata®Acera Surgical, Inc. · 2020-09-25K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017-04-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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