Musculoskeletal Transplant Foundation Recalls QuickGraft Model 430PST Due to Labeling Error
Musculoskeletal Transplant Foundation is recalling nine QuickGraft Model 430PST units because the label measurement was not taken under tension, potentially extending surgical time.
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. The hazard is a labeling error that may extend surgical time, which fits the criteria for moderate severity involving minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Musculoskeletal Transplant Foundation, Inc. is recalling nine units of QuickGraft Model # 430PST. The recall was initiated because the measurement listed on the product label was not taken under tension. This labeling error could cause a possible extension of the surgical time needed to complete the procedure.
The affected units were distributed in New York, North Carolina, Louisiana, Texas, Missouri, and Ohio. Specific serial numbers for the recalled units are 00319004921075, 00319004921073, 00319007681048, 00319014411085, 00618052231059, 03319006511040, 03319009191029, 03319019231072, and 03519018121056.
Healthcare providers and consumers should check their inventory for these specific serial numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- QuickGraft¿ Model # 430PST
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- Affected units
- 9
Distribution
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