Evans Wedge Disposable Trials Orthopedic Surgical Instruments Recalled for Mixed Parts
restor3d Inc. is recalling Evans Wedge Disposable Trials orthopedic surgical instruments because parts were mixed into other lots during relabeling for extended shelf-life. The recall affects devices distributed nationwide across seven states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of a surgical instrument with mixed parts that could affect device function and safety. However, no illnesses, injuries, or hospitalizations have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
restor3d Inc. is recalling Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (Model 6101-20181018) orthopedic manual surgical instruments. The recalled lot is 2022010031 with UDI 00840097501574.
During a rework and relabeling process to extend the shelf-life of disposable instruments to four years, parts were inadvertently mixed into other lots. This mix-up could affect the safety and proper function of the surgical instruments.
The affected instruments were distributed nationwide in Kentucky, North Carolina, New Jersey, Texas, Indiana, Virginia, and Alabama. A total of 4 units were involved in this recall.
Healthcare facilities and surgical centers should immediately discontinue use of affected instruments from lot 2022010031 and contact restor3d Inc. for instructions on return or replacement. No injuries or illnesses have been reported.
The recalled product
- Product
- Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
- Manufacturer
- restor3d Inc.
- Affected units
- 4
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)
- Model: 6101-20181018
- Lot: 2022010031
- UDI: 00840097501574
Distribution
Part of a larger recall action
This product is one of 3 recalled by restor3d Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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