K-Wire, 1.35 mm x 170 mm
FDA Recall Z-1035-2022 · Posted None
Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2022-03-25
Date Terminated2026-05-15
Product Quantity300 pieces
Reason for Recall
Products do not meet length and diameter specifications.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.