Evans Wedge Orthopedic Surgical Instrument Recalled for Parts Mixed During Rework
restor3d Inc. is recalling 9 units of Evans Wedge Disposable Trials orthopedic surgical instruments because parts from different lots were mixed during a manufacturing rework and relabeling process.
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 FDA Class II recall involves a surgical instrument where parts from different lots were mixed during manufacturing rework. The potential for instrument non-conformance without reported injuries qualifies this as a 'risk-of-harm product where injury has not yet been reported' per the severity rubric.
Plain-English summary
restor3d Inc. is recalling 9 units of Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818), an orthopedic manual surgical instrument. The recall was initiated because parts from different production lots were inadvertently mixed together during an internal rework and relabeling process intended to extend the product's shelf-life to 4 years.
The affected products were distributed nationwide across Kentucky, North Carolina, New Jersey, Texas, Indiana, Virginia, and Alabama. The mixing of parts during the rework process could affect the instruments' conformance to their original specifications and labeling, potentially impacting surgical performance.
Hospitals and surgical facilities that have received units with Model 6101-22200818, Lot 2022010035, or UDI 00840097501598 should immediately discontinue use and contact restor3d Inc. for instructions on return and replacement of the affected instruments. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
- Manufacturer
- restor3d Inc.
- Affected units
- 9
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: 6101-22200818
- Lot: 2022010035
- UDI: 00840097501598
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.
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