Recall Z-2827-2020— Smith & Nephew Orthopaedics AG

Name: FDA recall Z-2827-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-22

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Orthopaedics AG, initiated 2020-07-22. It names one FDA 510(k) clearance: K143739. 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.. Reason: Multiple lots being recalled due to a product design issue.

Recalling firm: Smith & Nephew Orthopaedics AG
Classification: Class II
Status: Ongoing
Initiated: 2020-07-22
Firm location: Aarau, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K143739 — POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.·cleared 2015-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.