Device product
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 on the inner reamer guide.
Z-2827-2020
Product summary
- Event
- Event 86099
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 528 unit
- Official record key
device-enforcement:Z-2827-2020
Official wording
Reason: Multiple lots being recalled due to a product design issue
Code information: Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689
Distribution pattern: 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.
Derived failure modes
-
Device software or design
design issue