Z-1976-2013Class I

Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning...

Name: Z-1976-2013 Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning...
Creator: Stryker Spine
Published: 2013-05-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-05-30 / Terminated

FDA source

Stryker Spine began a recall of 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 on 2013-05-30. FDA classified it as Class I and gives the reason as "Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1976-2013
Classification: Class I
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-08-22
Terminated: 2014-12-30
Recalling firm: Howmedica Osteonics Corp
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.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
FDA root cause: Other
Action: Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well. Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex.
Quantity in commerce: 1536 units (US) 880 (Foreign)
Distribution: Nationwide Distribution.
Product codes and lots: K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1976-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1976-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22

Product code KWP

K093670Class IIModification to: Oasys SystemStryker Spine / cleared 2010-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)