Home / Recalls / Smith & Nephew Orthopaedics AG / Z-2827-2020

Z-2827-2020 Class II Terminated

Recalled by Smith & Nephew Orthopaedics AG — Aarau, N/A

FDA device recall Z-2827-2020 was initiated by Smith & Nephew Orthopaedics AG on July 22, 2020 and is designated Class II. Reason for recall: Multiple lots being recalled due to a product design issue The recall status is terminated (terminated August 21, 2026). Affected quantity: 528 unit.

Recall Details

Product Type: Devices
Report Date: August 26, 2020
Initiation Date: July 22, 2020
Termination Date: August 21, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 528 unit

Product Description

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.

Reason for Recall

Multiple lots being recalled due to a product design issue

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.

Code Information

Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689