The Recall Desk
HighFDA (Devices)·Z-1035-2022·Announced 2022-05-11

K-Wire Devices Recalled for Incorrect Length and Diameter Specifications

Arthrex is recalling 300 K-Wire orthopedic devices that do not meet specified length and diameter requirements. Incorrect dimensions may affect surgical function.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for dimensional specification defects. No illnesses or injuries have been reported. The score reflects a risk-of-harm product where injury has not yet been reported, per the rubric.

Plain-English summary

Arthrex, Inc. is recalling 300 K-Wire orthopedic devices (Part Number AR-8610K-43, Batch 1298116640) due to products not meeting specified length and diameter requirements.

K-Wires are medical devices used in orthopedic surgery for bone fixation. When dimensions do not meet specifications, the devices may not function as intended during surgical procedures.

The recalled devices were distributed worldwide, with US distribution in Ohio, Tennessee, Missouri, Louisiana, Iowa, Arizona, Pennsylvania, New York, and Oregon, as well as to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain. The recall was issued by the FDA as a Class II recall.

The recalled product

Product
K-Wire, 1.35 mm x 170 mm
Manufacturer
Arthrex, Inc.
Category
Medical Device — Orthopedic / Surgical
Hazard
Affected units
300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number: AR-8610K-43
  • Batch 1298116640 UDI: 00888867197084

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Related recalls

Same manufacturer · Arthrex, Inc.

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