Z-1310-2021Class II

Drill Bit, Cannulated, 5.0 mm -

Name: Z-1310-2021 Drill Bit, Cannulated, 5.0 mm -
Creator: Arthrex, Inc.
Published: 2021-02-24
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2021-02-24 / Terminated

FDA source

Arthrex, Inc. began a recall of Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures on 2021-02-24. FDA classified it as Class II and gives the reason as "The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1310-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-24
Posted: 2021-03-26
Terminated: 2023-05-02
Recalling firm: Arthrex GmbH
Product: Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Product code: HTW Bit, Drill
Reason for recall: The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
FDA root cause: Under Investigation by firm
Action: Consignees were notified via e-mail with URGENT: RECALL NOTIFICATION dated 02/23/2021. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.
Quantity in commerce: 9 units
Distribution: US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
Product codes and lots: Product Code AR-8770-02, Lot Number 032052

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1310-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1310-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-26

Product code HTW

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)