Food, drugs, devices › Arthrex, Inc.
Device recall: K-Wire, 1.35 mm x 170 mm
FDA enforcement event 89984 is a device recall by Arthrex, Inc. of Naples, FL, initiated 25 Mar 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 15 May 2026. Initiation: voluntary: firm initiated. Arthrex, Inc. has 18 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Arthrex, Inc., Naples, FL.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1035-2022 | K-Wire, 1.35 mm x 170 mm | 300 pieces | Class II | Terminated | 11 May 2022 |
Context
Other enforcement events for Arthrex, Inc.
All 18 events for Arthrex, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Products do not meet length and diameter specifications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 May 2026. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.