Arthrex, Inc.: K-Wire, 1.35 mm x 170 mm

Is my product affected?

K-Wire, 1.35 mm x 170 mm

• UPC 00888867197084

Check against the official notice below — it lists the full affected range.

What happened

Arthrex, Inc. is recalling 300 pieces of K-Wire products (Part Number AR-8610K-43, Batch 1298116640) because they do not meet the specified length and diameter requirements. The affected products were distributed worldwide, including throughout the United States in Ohio, Tennessee, Missouri, Louisiana, Iowa, Arizona, Pennsylvania, New York, and Oregon, as well as in Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.

The recall record does not specify a remedy or instructions for affected consumers regarding what they should do with the recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Products do not meet length and diameter specifications.

Details from the source

Reason for recall: Products do not meet length and diameter specifications. 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. Quantity: 300 pieces Lot/code info: Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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