PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: August 26, 2020 Initiated: July 22, 2020 #Z-2827-2020

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

Details

Units Affected
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.
Location
Aarau, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Smith & Nephew Orthopaedics AG. Units affected: 528 unit.
Why was this product recalled?
Multiple lots being recalled due to a product design issue
Which agency issued this recall?
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2827-2020.