Z-2912-2018Class II

AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the...

Name: Z-2912-2018 AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the...
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2018-06-22
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2018-06-22 / Terminated / root cause: packaging

FDA source

Stryker Leibinger GmbH & Co. KG began a recall of AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium on 2018-06-22. FDA classified it as Class II and gives the reason as "After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2912-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-22
Posted: 2018-08-29
Terminated: 2019-07-08
Recalling firm: Stryker Leibinger GmbH & Co. KG
Product: AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Product code: GWO Plate, Cranioplasty, Preformed, Alterable
Reason for recall: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to [email protected]. 4. Keep a copy of the completed and executed Customer response Form for your records.
Quantity in commerce: 22,831 total
Distribution: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Product codes and lots: 1000201620, 1000203741, 1000215161, 1000221838, 1000224226, 1000230171, 1000232403, 1000233774, 1000235432, 1000236133, 1000238416, 1000245179, 1000251379, 1000254404, 1000255711, 1000257449, 1000258651, 1000258652, 1000259409, 1000260283, 1000260284, 1000260285, 1000261025, 1000261026, 1000261689, 1000261690, 1000261691, 1000263498, 1000263499, 1000263500, 1000263501, 1000263502, 1000264407, 1000264408, 1000265423, 1000265424, 1000266165, 1000266166, 1000266167, 1000267009, 1000267010, 1000267748, 1000267749, 1000267750, 1000268573, 1000268574, 1000269518, 1000269519, 1000270162, 1000270163, 1000270837, 1000270838, 1000285715, 1000287395, 1000289257, 1000201620, 1000288210, 1000290246, 1000291275, 1000292116, 1000294081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2912-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2898-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2899-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2900-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2901-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2902-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2903-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2904-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2905-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2906-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2907-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2908-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2909-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2910-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2911-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2912-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2913-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2914-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2915-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29

Product code GWO

K120352Class IIStryker Quikflap Sterile Procedure PackStryker / cleared 2012-06-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)