Musculoskeletal Transplant Foundation Recalls Allofix Insertion Kits Due to Drill Size Labeling Error
Musculoskeletal Transplant Foundation is recalling 117 Allofix Insertion Kits because they are labeled as 2.0mm but may contain 2.4mm drills.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding drill size, which is a moderate risk without reported injuries.
Plain-English summary
Musculoskeletal Transplant Foundation, Inc. is recalling 117 units of the Allofix Insertion Kit, 2.0 mm, Single Drill. The recall is due to a labeling error where the kits are marked as containing a 2.0mm diameter drill, but they may actually contain a 2.4mm diameter drill.
The affected product is identified by Product Code 900920, Serial Number 906912041001, and an expiration date of 01Mar2017. These kits are designed for orthopedic surgeons to be used in conjunction with allografts and are intended for single use only.
The affected units were distributed nationwide in Arizona, California, Colorado, Florida, Illinois, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Utah, Washington, and West Virginia. Healthcare providers and patients should check their inventory for the specific serial number and stop using the affected kits if found.
The recalled product
- Product
- Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- Affected units
- 117
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)
- Product Code: 900920
- Serial #:906912041001
- Expiry date 01Mar2017
Distribution
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