FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: K-Wire, 1.35 mm x 170 mm
- Recall number
- Z-1035-2022
- Recalling firm
- Arthrex, Inc.
- Product
- K-Wire, 1.35 mm x 170 mm
- Status
- Terminated
- Initiated
- 2022-03-25
- Posted
- not on file
- Terminated
- 2026-05-15
- Reason
- Products do not meet length and diameter specifications.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent a recall notification to the consignees on 03/25/2022 via email. The consignees were instructed to discontinue use, sale, and distribution of the product. The consignees were also instructed to contact FLS@arthrex.com to arrange return of the affected product.
- Quantity
- 300 pieces
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.
- Lot, serial or model codes
- Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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