U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
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: FDA Class II medical device recall with a manufacturing defect that prevents proper assembly of a surgical instrument component. Per rubric, risk-of-harm products where injury has not yet been reported qualify as High severity.
Plain-English summary
United Orthopedic Corp. is recalling 2 units of the U2 Total Knee System femoral valgus adaptor, model numbers 9323-5333 and 9323-5334. These manual orthopedic surgical instruments are used in knee replacement surgery.
The recall is being initiated due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. This manufacturing defect could affect the instrument's ability to function correctly during surgical procedures.
The affected products were distributed nationwide in the states of Texas and Michigan. The specific product numbers and lot codes are tracked through UDI-DI codes 04719886908084 (lot 25FB50) and 04719886908091 (lot 25FB51).
Healthcare facilities and surgical centers that received these products should stop using them immediately and contact United Orthopedic Corp. for replacement or refund. Patients who have already undergone surgery with these devices should consult with their surgeon if they experience any unusual symptoms.
The recalled product
- Product
- Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
- Manufacturer
- United Orthopedic Corp.
- Affected units
- 2
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 (7)
- Product Number
- UDI-DI Code
- Lot Code: Product number 9323-5333
- UDI-DI 04719886908084
- Lot number 25FB50 Product number 9323-5334
- UDI-DI 04719886908091
- Lot number 25FB51
Distribution
Part of a larger recall action
This product is one of 4 recalled by United Orthopedic Corp. 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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