Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and be

FDA device recall Z-1991-2016 · posted 2016-06-14 · Terminated

Recall details

Recalling firm

CarboFix Orthopedics, Ltd.

Reason for recall

Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

Action taken

On May 10, 2016, an advisory notice was issued to all distributors that currently may possess (or supplied to hospital) the product. The notice was sent to a representative of the distributor companies via an e-mail (using confirm receipts for delivery and notification when the email is read), together with a letter to hospital(s) for the representative to use in case the distributor supplied the product to the hospital. The letter requested that the product be returned and also requested a sub-recall.

Root cause

Other

Status

Terminated

Product code

HSB

Quantity affected

638

Distribution

AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA

Date initiated

2016-05-10

Date posted

2016-06-14

Date terminated

2017-01-27

Location

Herzliya, Israel

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