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Open, Classified

GS0008 2Y - Burn Pack - STL, Item Number 880082025

FDA Recall Z-0070-2024 · Posted 2023-10-06

Recalling FirmROi CPS LLC
Recall StatusOpen, Classified
Product CodeOJJ
Date Initiated2023-09-11
Product Quantity103 kits

Reason for Recall

Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.

Firm Action

ROi CPS, LLC issued a Medical Device Correction notice to its sole consignee on 09/11/2023 by email. The notice explained the issue with the Zimmer Dermatone Blade contained in the kit, the risk, and requested the consignee affix a sticker to the exterior of the kit requesting that the blade be removed and discarded at the time of use.

Root Cause

Other

Distribution Pattern

Missouri

Official Source

View FDA Recall →

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

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