Stryker AXS PP Cranium Plates Recall: Packaging Compromise Risk
Stryker recalls AXS PP cranium plates with potential packaging compromise after three years. Affected units include specific part numbers; contact for return instructions.
Lower-risk recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Contact the company
What happened, in plain English
Stryker is recalling cranium plates that may have compromised sterile packaging after three years. This could lead to infection risks if the packaging fails during surgery. Read more at govinfonow.com/recall/70749-stryker-axs-pp-cranium-plates-recall-packaging-compromise-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/70749-stryker-axs-pp-cranium-plates-recall-packaging-compromise-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2910-2018
Cite this page
“Stryker AXS PP Cranium Plates Recall: Packaging Compromise Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70749-stryker-axs-pp-cranium-plates-recall-packaging-compromise-risk. Based on FDA recall #Z-2910-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2910-2018%22&limit=1).
Why it’s dangerous
After three years, the external sterile packaging might become compromised, potentially allowing contamination. This could increase infection risk during surgical procedures if the packaging fails.
Who’s affected
Medical professionals using these plates for cranium surgery are most at risk. Patients receiving the plates during surgery may be affected if the packaging fails.
How to tell if you have this one
Check for part numbers 1000201514, 1000203740, 1000216825, and other listed numbers on the packaging. These plates are used for cranium surgery and were sold with specific part numbers.
- Brand
Stryker- Category
Medical device
All 18 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
| Recall number | Product, codes & lots |
|---|---|
| Z-2898-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).; 1000085083, 1000089303, 1000089990, 1000095193, 1000100539, 1000104523, 1000107792, 1000110518, 1000116215, 1000124115, 1000129492, 1000134144, 1000139985, 1000146194, 1000151496, 1000156358, 1000164801, 1000167015, 1000170704, 1000174837, 1000178195, 1000181123, 1000183608, 1000188543, 1000192851, 1000197301, 1000209029, 1000219395, 1000221066, 1000237512, 1000239649, 1000240995, 1000251376, 1000259411, 1000275865, 1000286361, 1000290245 |
| Z-2899-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).; 1000193584 |
| Z-2900-2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.; 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 |
| Z-2901-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium; 1000225769, 1000239651, 1000254801 |
| Z-2902-2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium; 1000213465, 1000239652, 1000245174, 1000255707 |
| Z-2903-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium; 1000221067, 1000239653, 1000245175, 1000261686 |
| Z-2904-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium; 1000107793, 1000107794, 1000107795, 1000111407, 1000113293, 1000119681, 1000119682, 1000124116, 1000130031, 1000134145, 1000139203, 1000141585, 1000148808, 1000150571, 1000156031, 1000159892, 1000166365, 1000168534, 1000169198, 1000170705, 1000171359, 1000174838, 1000176391, 1000183609, 1000188544, 1000189237, 1000191063, 1000193586, 1000195789, 1000202429, 1000215159, 1000217674, 1000220165, 1000224225, 1000231906, 1000233773, 1000236827, 1000239654, 1000245176, 1000251377, 1000254803, 1000262514 |
| Z-2905-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium; 1000181748, 1000295062 |
| Z-2906-2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium; 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 |
| Z-2907-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium; 1000230170, 1000235431, 1000265421 |
| Z-2908-2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium; 1000232402, 1000237513 |
| Z-2909-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium; 1000167017, 1000167829, 1000171360, 1000172321, 1000173866, 1000175689, 1000178993, 1000187364, 1000198471, 1000198472, 1000202431, 1000205662, 1000215879, 1000217675, 1000226524, 1000233194, 1000238414, 1000259405 |
| Z-2910-2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium; 1000201514, 1000203740, 1000216825, 1000220166, 1000233195, 1000237514, 1000238415, 1000245178, 1000252563, 1000254189, 1000254403, 1000255709, 1000256557, 1000257448, 1000258647, 1000258648, 1000258649, 1000259406, 1000259407, 1000260281, 1000260282, 1000261023, 1000261024, 1000261687, 1000261688, 1000262515, 1000262516, 1000262517, 1000263497, 1000264403, 1000264404, 1000264405, 1000265422, 1000268571, 1000268572, 1000201514, 1000287394, 1000292115, 1000293285, |
| Z-2911-2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium; 1000201582, 1000254804, 1000258650, 1000259408, 1000261022, 1000262518, 1000262519 |
| 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 cranium; 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 |
| Z-2913-2018 | 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; 1000201635, 1000215162, 1000230807, 1000236134, 1000253512, 1000256558, 1000258653, 1000260286, 1000263503, 1000261692, 1000265425, 1000265426 |
| Z-2914-2018 | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium; 1000201581, 1000215163, 1000230808, 1000252564, 1000256560, 1000259410, 1000260287, 1000263504, 1000211563, 1000267011, 1000267751 |
| Z-2915-2018 | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium; 1000201577, 1000215164, 1000218602, 1000248070, 1000254405, 1000261028, 1000262520, 1000264409, 1000266168, 1000288211, 1000289258, 1000292117 |
What to do — step by step
Check Packaging Condition
Inspect the external sterile packaging for signs of compromise after three years of use.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
FDA distribution: “US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, New Hampshire, Ohio.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2910-2018 (June 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2910-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.