FDA Device recall Z-2401-2018
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S by Stryker, citing the manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2401-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-27 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker |
| Distribution | AL, FL, KY, NC, TN, UT, WA |
Product
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
Reason
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Identifiers
| code_info | GTIN: 04546540200693; Lot code: K08327F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2401-2018%22
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