FDA Device recall Z-0483-2018
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM by Zimmer Biomet, citing during the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no long….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0483-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-07 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
Reason
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Identifiers
| code_info | Item No. 814509420; Lot No. (Exp. Date) UDI: 398610 (05/19/2027) UDI (01)00887868038938 (17)270519 (10)398610; 858830 (…Item No. 814509420; Lot No. (Exp. Date) UDI: 398610 (05/19/2027) UDI (01)00887868038938 (17)270519 (10)398610; 858830 (06/13/2027) UDI (01)00887868038938 (17)270613 (10)858830; 858930 (06/13/2027) UDI (01)00887868038938 (17)270613 (10)858930 |
|---|
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-0483-2018%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.