Z-0361-2020Class II

2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the...

Name: Z-0361-2020 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the...
Creator: Exactech, Inc.
Published: 2019-10-02
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2019-10-02 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product... on 2019-10-02. FDA classified it as Class II and gives the reason as "Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0361-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-02
Posted: 2019-11-12
Terminated: 2023-05-19
Recalling firm: Exactech, Inc.
Product: 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
Product code: NDL Pin, Fixation, Smooth, Metallic
Reason for recall: Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Exactech notified customers on about 10/02/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that the 2.4mm x 2.5" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled. Instructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to [email protected].
Quantity in commerce: 9 units
Distribution: US Nationwide distribution in the states of GA, NY, OH, VA.
Product codes and lots: Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273); Packaging Lots Numbers (49079322, 49079321); Manufacturing Lot Number:19030412

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0361-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0361-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-12

Product code NDL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)