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Lower risk Medical device recall · FDA · Published March 1, 2019

Zimmer Biomet Hip Screw Recall: Confusing Screw Sizes May Cause Errors

Zimmer Biomet recalls hip screws that may be mislabeled as 20mm when they are 30mm, risking surgical errors. Affected units include specific lot numbers. Contact for replacement.

🇺🇸 FDA recall #Z-1086-2019Medical deviceZimmer Biomet ›
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Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling hip screws that could be mislabeled as 20mm when they are actually 30mm. This confusion might lead to surgical errors during hip replacement procedures. Read more at govinfonow.com/recall/68918-zimmer-biomet-hip-screw-recall-confusing-screw-sizes-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/68918-zimmer-biomet-hip-screw-recall-confusing-screw-sizes-may-cause · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1086-2019

Cite this page

“Zimmer Biomet Hip Screw Recall: Confusing Screw Sizes May Cause Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68918-zimmer-biomet-hip-screw-recall-confusing-screw-sizes-may-cause. Based on FDA recall #Z-1086-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1086-2019%22&limit=1).

The FDA announced on March 1, 2019, that Zimmer Biomet, Inc. is recalling the Biomet RingLoc Hip System Self-Tapping Bone Screw due to potential packaging errors involving screw lengths. This voluntary Class II recall affects 809 units distributed worldwide.

How to tell if you have it

  • Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium
  • UPC: 00880304001961
  • Lot Numbers: 523430, 523450, 860840, 860850, 860860

The hazard

Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Other recent recalls of similar products include the Zimmer Biomet Spinal Rod Cutter Recall (Nov. 20, 2020), the Zimmer Biomet Polaris 5.5 Spinal System Recall (Nov. 17, 2020), and the Zimmer Biomet Hip Cup Recall (Sept. 24, 2020). Other recent recalls of similar products include the Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), the Tornier Perip Screw Recall (Dec. 19, 2025), and the Zimmer Affixus Femoral Nails Recall (Dec. 2, 2025).

How to tell if you have this one

Check for lot numbers 523430, 523450, 860840, 860850, or 860860 on the packaging. The product is a self-tapping bone screw used with total hip implants.

  • Brand
    Zimmer Biomet
  • Product
    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item
  • Category
    Medical device
FDA recall event · 2 products

All 2 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
    Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Recall numberProduct, codes & lotsQuantity
Z-1086-2019Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant; Lot Numbers/UDI Number 523430 (01) 00880304001961 (17) 280804 (10) 523430 523450 (01) 00880304001961 (17) 280727 (10) 523450 860840 (01) 00880304001961 (17) 280806 (10) 860840 860850 (01) 00880304001961 (17) 280809 (10) 860850 860860 (01) 00880304001961 (17) 280806 (10) 860860809 total
Z-1087-2019Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant; Lot Numbers/UDI Number 859960 (01) 00880304008700 (17) 280809 (10) 859960 859980 (01) 00880304008700 (17) 280805 (10) 859980 860120 (01) 00880304008700 (17) 280806 (10) 860120 860310 (01) 00880304008700 (17) 280823 (10) 860310 860580 (01) 00880304008700 (17) 280807 (10) 860580809 units total
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Zimmer Biomet for guidance on the specific lot numbers and replacement options.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Mar 1, 201912. FDA classified it Class II: Apr 4, 201923. Published in FDA’s Enforcement Report: Apr 10, 201934. FDA terminated the recall: May 27, 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-1086-2019 (March 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1086-2019 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