Orthopedic Surgery Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE LEMPERT BONE RONG orthopedic surgery kits due to packaging defects that may compromise sterility. The affected kits (Model 96-4780A, Lot HSI) were distributed nationwide.
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 recall involving a potential sterile barrier breach on surgical instruments. While no illnesses or injuries have been reported, the theoretical risk of sterility compromise on devices used in orthopedic procedures represents a significant risk of harm.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE LEMPERT BONE RONG 6.25" STER25 orthopedic surgery kits (Model 96-4780A) distributed nationwide due to packaging defects that may compromise the sterile barrier. The affected lot code is HSI.
The reported packaging issues may result in a breach of the sterile barrier, which is essential for maintaining the sterility of medical devices intended for surgical use.
Healthcare facilities and surgical centers that have received these kits should cease use immediately and contact Sklar Instruments for return instructions.
For additional information, refer to FDA recall Z-0952-2025.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- contamination-risk
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)
- 96-4780A
- UDI/DI 50649111488021
- Lot codes: HSI
Distribution
Distributed nationwide across the United States.
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