K-Wire, 1.35 mm x 170 mm
This recall is currently active, issued March 25, 2022. It was issued by Arthrex, Inc..
- Company
- Arthrex, Inc.
- Recall Initiated
- March 25, 2022
- Recall Number
- Z-1035-2022
- Quantity
- 300 pieces
- Firm Location
- Naples, FL
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084
Root Cause
Nonconforming Material/Component
Action Taken
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 FLS@arthrex.com to arrange return of the affected product.