Exact FDA event identifier

Event 78668

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

Event summary

Timeline bucket: November 17, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Stryker Corporation

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

4 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 4

StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

Z-0835-2018

Recall number: Z-0835-2018
Initiated: November 17, 2017
Classification: Class II
Status: Terminated
Recalling firm: Stryker Corporation
Quantity: 60,753 units total

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

bioburden testing of certain lots were found

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Code information

a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520; b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2; c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2

Distribution pattern

Distributed domestically to . Distributed internationally to Australia and Mexico.

device · product 2 of 4

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

Z-0836-2018

Recall number: Z-0836-2018
Initiated: November 17, 2017
Classification: Class II
Status: Terminated
Recalling firm: Stryker Corporation
Quantity: 60,753 units total

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

bioburden testing of certain lots were found

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Code information

a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;

Distribution pattern

Distributed domestically to . Distributed internationally to Australia and Mexico.

device · product 3 of 4

STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

Z-0837-2018

Recall number: Z-0837-2018
Initiated: November 17, 2017
Classification: Class II
Status: Terminated
Recalling firm: Stryker Corporation
Quantity: 60,753 units total

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

bioburden testing of certain lots were found

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Code information

Model 0234010056, UDI 04546540754561, Lot No. 17278AG2

Distribution pattern

Distributed domestically to . Distributed internationally to Australia and Mexico.

device · product 4 of 4

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Z-0838-2018

Recall number: Z-0838-2018
Initiated: November 17, 2017
Classification: Class II
Status: Terminated
Recalling firm: Stryker Corporation
Quantity: 60,753 units total

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

bioburden testing of certain lots were found

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

Code information

Model 0234020280, UDI 07613154643264, Lot No. 17299AG2

Distribution pattern

Distributed domestically to . Distributed internationally to Australia and Mexico.