CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires
CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.
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 3/5 (High).
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: The recall involves a risk-of-harm product (sterility compromise in a medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
CarboFix Orthopedics, Ltd. is recalling 638 units of the Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire. These medical devices are used for the fixation of fractures in the proximal and distal thirds of long bones. The recall was initiated after the firm received complaints that the guide wires had penetrated their internal packaging, which compromised the sterility of the product.
The affected units are identified by Catalog Number PFT912250 and specific lot numbers including QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, and QTN04161A. The products were distributed to healthcare facilities in Alabama, Arizona, California, Colorado, the District of Columbia, Florida, Georgia, Indiana, Kansas, Kentucky, Maryland, Michigan, Nebraska, Nevada, New York, Ohio, Oklahoma, Texas, and Washington.
Healthcare providers should stop using the affected guide wires and contact CarboFix Orthopedics for instructions on return or replacement. Patients who have had these specific devices implanted should consult their healthcare provider to discuss the potential implications of the compromised sterility.
The recalled product
- Product
- Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
- Manufacturer
- CarboFix Orthopedics, Ltd.
- Affected units
- 638
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 (12)
- Catalog Number PFT912250 - Lot Number QTN90712
- QTN02700
- QTN61401
- QTN02785A
- QTN61402
- QTN83201B
- QTN61402A
- QTN43801
- QTN43801A
- QTN43801B
- QTN83201C
- QTN04161A
Distribution
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