Stryker Leibinger GmbH & Co. KG: Medical Device Recall in 2018 - (Recall #: Z-2900-2018)

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 12-01522S, for use on the cranium.

Product Classification:

Class II

Date Initiated: June 22, 2018

Date Posted: September 5, 2018

Recall Number: Z-2900-2018

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:

1000096159, 1000096935, 1000096936, 1000097334, 1000097915, 1000101820, 1000109424, 1000115216, 1000119029, 1000125079, 1000125080, 1000130030, 1000136426, 1000141584, 1000147073, 1000151497, 1000156030, 1000157137, 1000162227, 1000163908, 1000167016, 1000169751, 1000176390, 1000178196, 1000181747, 1000184371, 1000186595, 1000187362, 1000191062, 1000193585, 1000194476, 1000199414, 1000205660, 1000210937, 1000211803, 1000212626, 1000214335, 1000222495, 1000233193, 1000239650, 1000247182, 1000256556, 1000266164, 1000270836, 1000277104, 1000283590, 1000287393, 1000294080, 1000086193, 1000298088

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