MTF Recalls Allograft Cortical Pins Due to Diameter Labeling Error
Musculoskeletal Transplant Foundation is recalling one lot of Allograft Cortical Pins because the 2.0 mm label may contain 2.4 mm pins.
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, but the source text does not report any hospitalizations, injuries, or illnesses. It is a labeling error regarding product specifications, fitting the criteria for a moderate severity recall.
Plain-English summary
Musculoskeletal Transplant Foundation (MTF) is recalling one lot of its Allograft Cortical Pins. The recall is due to a labeling error where the product is labeled as a 2.0 mm diameter pin, but the lot may contain a 2.4 mm diameter pin.
The affected product is identified by Lot #06512078901017 and Item #400920. The tissue is placed in a retainer and sealed in a blister pack. The recall involves 22 units.
The product was distributed in the states of Arizona, Colorado, Michigan, Minnesota, North Carolina, Ohio, and Texas. Healthcare providers and patients should check their inventory and records for this specific lot number and discontinue use if found.
The recalled product
- Product
- Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- Affected units
- 22
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 (2)
- Lot #06512078901017
- Item #400920. The tissue is placed in a retainer and sealed in a blister pack
Distribution
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