RecallRadar

FDA Device recall Z-0070-2024

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

On 2023-10-11 the FDA classified a Class II recall of GS0008 2Y - Burn Pack - STL, Item Number 880082025 by Roi Cps, citing 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 t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0070-2024
ClassificationClass II
Statusongoing
Initiated2023-09-11
Published2023-10-11
Last updated2026-09-13 11:56 UTC
CompanyRoi Cps
DistributionMO

Product

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

Reason

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.

Identifiers

code_infoUDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.