FDA Device recall Z-2170-2021
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast
- FDA Device
- Class II
- ongoing
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class II recall of Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast by Stryker, citing the devices have a different inner diameter than the diameter specified on the outer box label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2170-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-27 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker |
| Distribution | US |
Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Reason
The devices have a different inner diameter than the diameter specified on the outer box label.
Identifiers
| code_info | GTIN 07613327005417, Lot Number K03CC50 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2170-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.