K-Wire, 1.35 mm x 170 mm recallZ-1035-2022 · Arthrex, Inc. · initiated Mar 25, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arthrex, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products do not meet length and diameter specifications.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] to arrange return of the affected product.
Recall details
- Recall number
- Z-1035-2022
- Status
- Terminated
- Initiated by the company
- Mar 25, 2022
- Recalling firm
- Arthrex, Inc.
- Quantity
- 300 pieces
- Product code
- LXH
- 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.
Product description
K-Wire, 1.35 mm x 170 mm
Code information (models, lots, serial numbers)
Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-8610K-43Arthrex, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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