FDA Device recall Z-1215-2019
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cuttin…
- FDA Device
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cuttin… by Stryker Instruments Div, citing during manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1215-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-19 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.
Reason
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Identifiers
| code_info | Serial/Lot Number 18247037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2019%22
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