FDA Device recall Z-1976-2013
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini
- FDA Device
- Class I
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class I recall of Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini by Stryker Spine, citing stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1976-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-05-30 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Spine |
| Distribution | US |
Product
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Reason
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Identifiers
| code_info | K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above |
|---|
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-1976-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.