Recall Z-1035-2022
Arthrex, Inc. · initiated March 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
K-Wire, 1.35 mm x 170 mm
Codes / lots: Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084
Reason for recall
Products do not meet length and diameter specifications.
FDA-determined 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.
Details
- Recall number
- Z-1035-2022
- Initiated
- March 25, 2022
- Terminated
- May 15, 2026
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 300 pieces
- 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.
- Recalling firm
- Arthrex, Inc., Naples, FL