Summary
The FDA issued a Class II for GS0008 2Y - Burn Pack - STL, Item Number 880082025 by ROi CPS LLC. Reason: Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin.
Details
Source
Device Recall
External ID
Z-0070-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Lot/Code Info: UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
Quantity Affected: 103 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.
Distribution
Missouri
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-11
Company
Republic, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ROi CPS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ROi CPS LLC have FDA actions?
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0070-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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