FDA Device recall Z-1755-2015
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma
- FDA Device
- Class III
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class III recall of Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma by Biomet, citing biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1755-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
Reason
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Identifiers
| code_info | Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650. |
|---|
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-1755-2015%22
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