Recall Z-1035-2022 ยท LXH Orthopedic Manual Surgical Instrument
Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
| Date | Mar 25, 2022 |
| Status | Terminated |
| Reason | Products do not meet length and diameter specifications. |
| Root cause | Nonconforming Material/Component |
| 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 FLS@arthrex.com to arrange return of the affected product. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.