Stryker Spine: Medical Device Recall in 2013 - (Recall #: Z-1976-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: May 30, 2013

Date Posted: August 28, 2013

Recall Number: Z-1976-2013

Event ID: 65777

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.

Status: Terminated

Product Quantity: 1536 units (US) 880 (Foreign)

Code Information:

K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated