FDA Device recall Z-2428-2015
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only by Stryker Howmedica Osteonics, citing stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2428-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-24 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | n/a |
Product
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Reason
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Identifiers
| code_info | Part Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101,…Part Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2; Part Number: 410-0003 (Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Stryker Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2428-2015%22
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