Nail Insertion Sleeve — Class II medical device recall Z-2171-2021
Ongoing recall by Stryker GmbH, reported 2021-08-11, distributed nationwide. The devices have a different inner diameter than the diameter specified on the outer box label.
| Recall number | Z-2171-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, Switzerland |
| Recall initiated | 2021-05-27 |
| Classified | 2021-07-30 |
| Reported by FDA | 2021-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 242 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04546540715357 |
| Lot numbers | K03CC4F |
| Model numbers | 18061406S |
Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Reason for recall
The devices have a different inner diameter than the diameter specified on the outer box label.
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-2171-2021. 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.