Stryker Leibinger GmbH & Co. KG: Medical Device Recall in 2018 - (Recall #: Z-2906-2018)

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:

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium

Product Classification:

Class II

Date Initiated: June 22, 2018

Date Posted: September 5, 2018

Recall Number: Z-2906-2018

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:

1000100540, 1000100541, 1000101992, 1000101994, 1000103661, 1000110486, 1000113766, 1000115217, 1000115218, 1000131912, 1000147952, 1000157990, 1000159893, 1000164241, 1000165529, 1000170706, 1000173343, 1000175688, 1000179042, 1000179720, 1000187363, 1000191064, 1000193587, 1000200400, 1000202174, 1000202430, 1000204636, 1000209030, 1000211804, 1000215160, 1000225770, 1000230169, 1000232401, 1000235430, 1000238413, 1000245177, 1000247183, 1000255708

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