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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80371

18 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 22, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Leibinger GmbH & Co. KG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

18 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 18

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).

Z-2898-2018
Recall number
Z-2898-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 2 of 18

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).

Z-2899-2018
Recall number
Z-2899-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000193584

Distribution pattern

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

device · product 3 of 18

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.

Z-2900-2018
Recall number
Z-2900-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

device · product 4 of 18

QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium

Z-2901-2018
Recall number
Z-2901-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000225769, 1000239651, 1000254801

Distribution pattern

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

device · product 5 of 18

QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium

Z-2902-2018
Recall number
Z-2902-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000213465, 1000239652, 1000245174, 1000255707

Distribution pattern

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

device · product 6 of 18

QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium

Z-2903-2018
Recall number
Z-2903-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000221067, 1000239653, 1000245175, 1000261686

Distribution pattern

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

device · product 7 of 18

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium

Z-2904-2018
Recall number
Z-2904-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 8 of 18

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium

Z-2905-2018
Recall number
Z-2905-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000181748, 1000295062

Distribution pattern

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

device · product 9 of 18

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

Z-2906-2018
Recall number
Z-2906-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

device · product 10 of 18

QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium

Z-2907-2018
Recall number
Z-2907-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000230170, 1000235431, 1000265421

Distribution pattern

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

device · product 11 of 18

QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium

Z-2908-2018
Recall number
Z-2908-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000232402, 1000237513

Distribution pattern

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

device · product 12 of 18

QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium

Z-2909-2018
Recall number
Z-2909-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000167017, 1000167829, 1000171360, 1000172321, 1000173866, 1000175689, 1000178993, 1000187364, 1000198471, 1000198472, 1000202431, 1000205662, 1000215879, 1000217675, 1000226524, 1000233194, 1000238414, 1000259405

Distribution pattern

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

device · product 13 of 18

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium

Z-2910-2018
Recall number
Z-2910-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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,

Distribution pattern

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

device · product 14 of 18

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium

Z-2911-2018
Recall number
Z-2911-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000201582, 1000254804, 1000258650, 1000259408, 1000261022, 1000262518, 1000262519

Distribution pattern

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

device · product 15 of 18

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

Z-2912-2018
Recall number
Z-2912-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 16 of 18

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

Z-2913-2018
Recall number
Z-2913-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

device · product 17 of 18

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

Z-2914-2018
Recall number
Z-2914-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000201581, 1000215163, 1000230808, 1000252564, 1000256560, 1000259410, 1000260287, 1000263504, 1000211563, 1000267011, 1000267751

Distribution pattern

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

device · product 18 of 18

AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium

Z-2915-2018
Recall number
Z-2915-2018
Initiated
June 22, 2018
Classification
Class II
Status
Terminated
Quantity
22,831 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier) to become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1000201577, 1000215164, 1000218602, 1000248070, 1000254405, 1000261028, 1000262520, 1000264409, 1000266168, 1000288211, 1000289258, 1000292117

Distribution pattern

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