Stryker Leibinger GmbH & Co. KG: Medical Device Recall in 2018 - (Recall #: Z-2913-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium

Product Classification:

Class II

Date Initiated: June 22, 2018

Date Posted: September 5, 2018

Recall Number: Z-2913-2018

Event ID: 80371

Reason for Recall:

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Status: Terminated

Product Quantity: 22,831 total

Code Information:

1000201635, 1000215162, 1000230807, 1000236134, 1000253512, 1000256558, 1000258653, 1000260286, 1000263503, 1000261692, 1000265425, 1000265426

Distribution Pattern:

US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated