FDA Device recall Z-2827-2020
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is…
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is… by Smith And Nephew Orthopaedics Ag, citing multiple lots being recalled due to a product design issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2827-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-22 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew Orthopaedics Ag |
| Distribution | US |
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
Identifiers
| upc | 00885556535493 |
|---|---|
| code_info | Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2827-2020%22
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