Recall Z-2733-2020 ยท HRS Plate, Fixation, Bone
Arthrex, Inc.
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
| Date | Jun 24, 2020 |
| Status | Terminated |
| Reason | Screws provided in packaging are 5mm shorter than intended |
| Root cause | Process control |
| Action | Arthrex initiated recall on 06/24/2020. The notification states the following: 1 . Immediately discontinue use, sale, and distribution of the product. 2. Direct Customers (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or complaints@arthrex.de. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 3. Arthrex Subsidiaries (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or complaints@arthrex |
| Quantity | 28 units |
| Distribution | International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141478 | ARTHREX FRACTURE PLATES AND SCREWS Arthrex, Inc., Jul 8, 2014 |