FDA Device recall Z-2426-2015
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of rHead Lateral Stem, Size 1, Do Not Reuse, Sterile 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-2426-2015 |
| 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
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
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: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058…Part Number: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; Part Number: 310-0001 (Lateral Assembly, Radial Implant, Size 2) Lot #'s 22629201, 22890801, 23424501, 23917001, 19453-S2, 19737-S2, 19765-S2, 19766-S2 and 19793-S2; Part Number:310-0002 (Lateral Assembly, Radial Stem Implant, Size 3) Lot #'s 22288401, 22629301, 23198901, 23434601, 23917101, 19678-S2, 19767-S2, 19768-S2, 19794-S2 and 19842-S2; Part Number: 310-0003 (Lateral Assembly, Radial Implant, Size 4) Lot #'s 22288501, 23199001, 23424701, 23917201, 19068-S2, 19679-S2, 19713-S2, 19738-S2, 19795-S2 and 19843-S2; Part Number: 310-0004 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size1) Lot #'s 22288601, 23424801, 19057-S2, 19067-S2, 19454-S2, 19739-S2, 19796-S2 and 19844-S2; Part Number: 310-0005 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2) Lot #'s 23424901, 23917301, 19063-S2, 191 |
|---|
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-2426-2015%22
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