Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published November 17, 2017

Stryker ACL Interface Screw Recall: Higher Bioburden Risk

Stryker recalls certain ACL Interface Screws (Model 0234010056) due to higher bioburden levels in some lots. Affected items may pose infection risks during surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0837-2018Medical deviceStryker ›
Take action

Contact the company

Recalling firmStryker Corporation5900 Optical Ct · San Jose, CA 95138-1400
✎ GovInfoNow plain-language explainer

Stryker is recalling specific ACL Interface Screws (Model 0234010056) because some batches had higher bioburden levels than expected. This could increase infection risk during surgical procedures. Read more at govinfonow.com/recall/72517-stryker-acl-interface-screw-recall-higher-bioburden-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72517-stryker-acl-interface-screw-recall-higher-bioburden-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0837-2018

Cite this page

“Stryker ACL Interface Screw Recall: Higher Bioburden Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72517-stryker-acl-interface-screw-recall-higher-bioburden-risk. Based on FDA recall #Z-0837-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2018%22&limit=1).

The FDA announced on 2017-11-17 that Stryker Corporation voluntarily recalled the STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056. The agency cited routine bioburden testing findings showing levels higher than internal acceptable rates for certain lots.

How to tell if you have it

  • Brand: Stryker
  • Product: STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM
  • Model: 0234010056
  • UDI: 04546540754561
  • Lot No.: 17278AG2

The hazard

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

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since 2017-12-21. Other recent recalls include the Stryker AHTO Tube Set Packaging Recall (2026-06-08), the Stryker Neptune Smart Docking Station Recall (2026-05-06), and the Stryker FluidSmart Urology Tube Set Recall (2026-04-09). Other recent recalls of similar products include the American Contract Systems Medical Kits Recall (2026-05-19), the Smith & Nephew BIOSURE HA Screw Recall (2025-11-24), and the Stryker BARD Dynamic Tip Steerable Recall (2026-04-10).

How to tell if you have this one

Check for the model number 0234010056 on the screw packaging. The lot number 17278AG2 is also associated with this recall.

  • Brand
    Stryker
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    Distributed domestically to . Distributed internationally to Australia and Mexico.
Recall numberProduct, codes & lots
Z-0835-2018StrykeFlow 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; 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
Z-0836-2018STRYKER 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);; 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;
Z-0837-2018STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.; Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
Z-0838-2018ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.; Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number 0234010056 and lot number 17278AG2 on the screw packaging.

How this recall unfolded

Recall timeline

FDA terminated this recall 6.2 years after the firm started it.

1. Firm started the recall: Nov 17, 201712. FDA classified it Class II: Mar 2, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Jan 29, 2024420172024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall is for higher bioburden levels in some screw batches, which could increase infection risk during surgery. However, the hazard level is low risk as the remedy focuses on checking and not immediate action.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

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-0837-2018 (November 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0837-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA