POLARSTEM COLLAR Reamer Guide — Class II medical device recall Z-2827-2020
Terminated recall by Smith & Nephew Orthopaedics AG, reported 2020-08-26, distributed nationwide. Multiple lots being recalled due to a product design issue
| Recall number | Z-2827-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Orthopaedics AG, Aarau, N/A, Switzerland |
| Recall initiated | 2020-07-22 |
| Classified | 2020-08-19 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2026-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 528 units |
| UPC / GTIN / UDI-DI | 00885556535493 |
| Serial numbers | A56281, A57539, A58660, A600630, A61590, A62616, A62689 |
| Model numbers | 75102205 |
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 for recall
Multiple lots being recalled due to a product design issue
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2827-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.