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Terminated

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

FDA Recall Z-1310-2021 · Posted None

Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2021-02-24
Date Terminated2023-05-02
Product Quantity9 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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