Medical Convenience Kit Recalled for Defective Dermatome Blades
ROi CPS LLC is recalling a medical convenience kit containing Zimmer dermatome blades that have caused 38 complaints of thin and non-uniform skin grafts in surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with a documented product defect. Although no hospitalizations or injuries have been reported, the 38 complaints demonstrate a pattern of product failure in a critical surgical application where defective blades directly compromise graft quality and surgical outcomes.
Plain-English summary
ROi CPS LLC is recalling the GS0008 2Y Burn Pack (Lot 97289, expiration July 16, 2025), a medical convenience kit containing Zimmer dermatome blades. The kit has been distributed in Missouri and is identified by UDI/DI 10194717113805.
Zimmer recalled the dermatome blades due to 38 documented complaints in which the blades produced thin and non-uniform skin grafts during use. The product defect affects the quality and integrity of surgical outcomes in skin grafting procedures.
Affected consumers and healthcare facilities should discontinue use of the recalled kit. Those who have used the affected blades should contact ROi CPS LLC for further instructions regarding replacement or return of the recalled product.
The recalled product
- Product
- GS0008 2Y - Burn Pack - STL, Item Number 880082025
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 103
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 10194717113805
- Lot Number 97289
- Exp Date 2025-07-16
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · ROi CPS LLC
See all →- HighNewborn Resuscitator Kit Recalled for Inline Spring Defect
FDA (Devices) · 2025-02-12
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighRegard Kit Decanters Recalled for Defective Sterile Packaging
FDA (Devices) · 2024-08-28
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- SevereRegard Dressing Change Kit Recalled Due to Defective Irrigation Solution
FDA (Devices) · 2024-01-10
Same hazard · blade defect
See all →- HighOphthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB
FDA (Devices) · 2024-08-28
- HighOphthalmic Surgical Knives Recalled Due to Sharpness Defect
FDA (Devices) · 2024-08-28
- HighOphthalmic Surgical Knives Recalled for Potential Sharpness Issues
FDA (Devices) · 2024-08-28
- HighAlcon Ophthalmic Surgical Knives Recalled for Sharpness Defects
FDA (Devices) · 2024-08-28
- HighOphthalmic surgical knives recalled due to reported sharpness defects
FDA (Devices) · 2024-08-28