RecallRadar

FDA Device recall Z-1310-2021

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures

On 2021-04-07 the FDA classified a Class II recall of Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures by Arthrex, citing the color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1310-2021
ClassificationClass II
Statusterminated
Initiated2021-02-24
Published2021-04-07
Last updated2026-09-13 11:56 UTC
CompanyArthrex
DistributionUS

Product

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

Reason

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Identifiers

code_infoProduct Code AR-8770-02, Lot Number 032052

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1310-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.