Recall Z-2827-2020 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Smith & Nephew Orthopaedics AG
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated o
| Date | Jul 22, 2020 |
| Status | Terminated |
| Reason | Multiple lots being recalled due to a product design issue |
| Root cause | Device Design |
| Action | On July 22, 2020, Urgent Medical Device recall notice was send out to customers. The notification states the following action to be taken: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table. 2. If you have no product to return, please put |
| Quantity | 528 unit |
| Distribution | Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA Smith & Nephew, Inc., Apr 20, 2015 |