FDA Device recall Z-2363-2015
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818
- FDA Device
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818 by Stryker Howmedica Osteonics, citing A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2363-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-12 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
Reason
A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
Identifiers
| code_info | Catalog #5901-S-4818, Lot MAC7C14. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2363-2015%22
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