Z-1035-2022Class II

K-Wire, 1.35 mm x 170 mm

Name: Z-1035-2022 K-Wire, 1.35 mm x 170 mm
Creator: Arthrex, Inc.
Published: 2022-03-25
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2022-03-25 / Terminated / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of K-Wire, 1.35 mm x 170 mm on 2022-03-25. FDA classified it as Class II and gives the reason as "Products do not meet length and diameter specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1035-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-25
Posted: 2022-05-05
Terminated: 2026-05-15
Recalling firm: Arthrex GmbH
Product: K-Wire, 1.35 mm x 170 mm
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Products do not meet length and diameter specifications.
Root cause tag: manufacturing process
FDA 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 [email protected] to arrange return of the affected product.
Quantity in commerce: 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.
Product codes and lots: Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1035-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1035-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-05-05

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)