United Orthopedic Recalls U2 Total Knee System Tibial Inserts
United Orthopedic Corporation is recalling 14 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling discrepancy without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
United Orthopedic Corporation is recalling 14 pieces of the U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick (Catalogue number 2303-5016). The recall was initiated after the company received a customer complaint report from a distributor on October 31, 2017, stating that the contents of the package did not match the product labeling.
The affected product is identified by Lot number 17B621AG. The U2 Total Knee system is indicated in knee arthroplasty for skeletally mature patients with severe knee pain and disability. The device was distributed worldwide, including in the United States, UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea, and South Africa.
Consumers and healthcare providers should stop using the affected tibial inserts and contact United Orthopedic Corporation for further instructions.
The recalled product
- Product
- U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due…
- Manufacturer
- United Orthopedic Corporation
- Hazard
- Affected units
- 14
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 (1)
- Lot number 17B621AG
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by United Orthopedic Corporation 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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