CLASS II Device recall · Reported 11 May 2022 · FDA Enforcement Report

K-Wire, 1.35 mm x 170 mm recalled by Arthrex

Arthrex is recalling K-Wire, 1.35 mm x 170 mm, distributed nationwide in the US. The recall was initiated on 25 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

Quantity recalled300 pieces

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1035-2022
FDA event ID: 89984
Recalling firm: Arthrex, Naples, FL
Classification: Class II
Status: Terminated
Recall initiated: 25 Mar 2022
FDA classified: 5 May 2022
Reported: 11 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Mar 2022	Recall initiated by company
5 May 2022	Classified by FDA	+41 days
11 May 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products do not meet length and diameter specifications.

Product as listed by the FDA

K-Wire, 1.35 mm x 170 mm

Where it was distributed

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.

Nationwide Arizona Iowa Louisiana Missouri New York Oregon Pennsylvania Tennessee

Questions about this recall

Is K-Wire, 1.35 mm x 170 mm recalled?

Yes. Arthrex recalled K-Wire, 1.35 mm x 170 mm on 25 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-1035-2022.

Why was it recalled?

Products do not meet length and diameter specifications.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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