Recall Z-1380-2021 ยท HRS Plate, Fixation, Bone
Arthrex, Inc.
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
| Date | Mar 11, 2021 |
| Status | Terminated |
| Reason | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. |
| Root cause | Under Investigation by firm |
| Action | A Recall notification letter titled, "URGENT: RECALL NOTIFCIATION" was sent to consignees on 03/11/2021 via email. The email sent to the consignees requested that the parts be returned. Additionally, the firm is currently awaiting all distributed units to be returned. The recalling firm requested that consignees immediately discontinue use, sale, and distribution of the product. Instructions were provided for Arthrex Agencies (North America), Arthrex Subsidiaries (LATAM and APAC), direct customers (EMEA), and Arthrex Subsidiaries (EMEA) as follows: Arthrex Agencies (North America): Please co |
| Quantity | 32 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032187 | ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM Arthrex, Inc., Sep 22, 2003 |