FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
- Recall number
- Z-1310-2021
- Recalling firm
- Arthrex, Inc.
- Product
- Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
- Status
- Terminated
- Initiated
- 2021-02-24
- Posted
- not on file
- Terminated
- 2023-05-02
- Reason
- The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
- 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
- 9 units
- Distribution
- US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
- Lot, serial or model codes
- Product Code AR-8770-02, Lot Number 032052
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 1220246
- Firm city
- Naples
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28