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Lower risk Medical device recall · FDA · Published June 18, 2019

Howmedica Osteonics Recalls Serrato Screws Due to Incorrect Length

Howmedica Osteonics recalls two types of Serrato polyaxial screws (90mm and 100mm) that were manufactured with incorrect lengths. This could lead to improper joint fixation during surgery.

🇺🇸 FDA recall #Z-2160-2019Medical deviceHowmedica Osteonics ›
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Recalling firmHowmedica Osteonics Corp.2 Pearl Ct · Allendale, NJ 07401-1611
✎ GovInfoNow plain-language explainer

Howmedica Osteonics is recalling two types of Serrato polyaxial screws because some were made with the wrong length. Using these screws could cause improper joint fixation during surgery, which may lead to complications. Read more at govinfonow.com/recall/67653-howmedica-osteonics-recalls-serrato-screws-due-to-incorrect-length.

Source Summary by GovInfoNow · govinfonow.com/recall/67653-howmedica-osteonics-recalls-serrato-screws-due-to-incorrect-length · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2160-2019

Cite this page

“Howmedica Osteonics Recalls Serrato Screws Due to Incorrect Length.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67653-howmedica-osteonics-recalls-serrato-screws-due-to-incorrect-length. Based on FDA recall #Z-2160-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2160-2019%22&limit=1).

The FDA announced on June 18, 2019, that Howmedica Osteonics Corp. recalled Serrato polyaxial screws due to discrepant lengths. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Howmedica Osteonics
  • Product: Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590
  • Product: Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
  • Lot codes: B88751, B90243
  • UPC: 07613327351576

The hazard

According to the FDA, lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length. Lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls include the Howmedica SCORPIO C-DOME/PATELLA Implants Recall (July 30, 2026), the Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025), the XTANT Medical Xpress Pedicle Screw System recall (Feb. 18, 2026), and the APTUS 2.8 TriLock Screw Recall (Jan. 9, 2026).

How to tell if you have this one

Check the catalog number and lot number on the screw packaging. Lot B88751 has 90mm screws that were made 100mm long, and Lot B90243 has 100mm screws that were made 90mm long.

  • Brand
    Howmedica Osteonics
  • Product
    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Screw Details

    Look for the catalog number and lot number on the screw packaging to determine if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Massachusetts, New York, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jun 18, 201912. FDA classified it Class II: Aug 5, 201923. Published in FDA’s Enforcement Report: Aug 14, 201934. FDA terminated the recall: May 22, 2020420192020
  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.

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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-2160-2019 (June 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2160-2019 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.
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