Z-1991-2016Class II

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

Name: Z-1991-2016 Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that...
Creator: CarboFix Orthopedics, Ltd.
Published: 2016-05-10
License: https://open.fda.gov/license/

CarboFix Orthopedics Inc. / initiated 2016-05-10 / Terminated / root cause: packaging

FDA source

CarboFix Orthopedics, Ltd. began a recall of 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... on 2016-05-10. FDA classified it as Class II and gives the reason as "Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1991-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-10
Posted: 2016-06-14
Terminated: 2017-01-27
Recalling firm: CarboFix Orthopedics Inc.
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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Quantity in commerce: 638
Distribution: AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
Product codes and lots: Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1991-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1991-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14

Product code HSB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)