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Lower risk Medical device recall · FDA · Published June 12, 2023

Tornier AEQUALIS FLEX REVIVE Screw Mix-Up: Short vs Standard Model

Tornier recalls 55 specific AEQUALIS FLEX REVIVE Assembly Screws (model ARS655118) due to labeling error with standard screws. This mix-up could cause incorrect assembly in medical devices.

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

🇺🇸 FDA recall #Z-2020-2023Medical deviceTornier ›
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Recalling firmTornier, Inc10801 Nesbitt Ave S · Bloomington, MN 55437-3109
✎ GovInfoNow plain-language explainer

Tornier is recalling 55 specific AEQUALIS FLEX REVIVE Assembly Screws (model ARS655118) because they were mislabeled as the standard length screw instead of the short length. This mix-up could lead to incorrect assembly in medical devices, potentially causing improper function or safety issues. Read more at govinfonow.com/recall/57859-tornier-aequalis-flex-revive-screw-mix-up-short-vs-standard.

Source Summary by GovInfoNow · govinfonow.com/recall/57859-tornier-aequalis-flex-revive-screw-mix-up-short-vs-standard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2020-2023

Cite this page

“Tornier AEQUALIS FLEX REVIVE Screw Mix-Up: Short vs Standard Model.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57859-tornier-aequalis-flex-revive-screw-mix-up-short-vs-standard. Based on FDA recall #Z-2020-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2020-2023%22&limit=1).

The FDA announced on June 12, 2023, that Tornier, Inc. is recalling AEQUALIS FLEX REVIVE Assembly Screw 0mm Short units due to labeling errors. The hazard involves a comingle/swap resulting in incorrect product identification on the device.

How to tell if you have it

  • Brand: Tornier
  • Product: AEQUALIS FLEX REVIVE Assembly Screw 0mm Short
  • Model Number: ARS655118
  • UPC: 00846832069408
  • Serial Numbers: AZ1322077001 through AZ1322077055

The hazard

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Context

GovInfoNow's records show Tornier, Inc has 12 other recalls on record since 2018-02-08. Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System (2026-02-18), APTUS 2.8 TriLock Screw Recall (2026-01-09), and Orthof: Minirail Fixator M122 Labeled Incorrectly - Recall (2026-06-10).

How to tell if you have this one

Check for model number ARS655118 on the screw packaging or label. The screws have serial numbers starting with AZ1322077001 to AZ1322077055. They were sold with the GTIN 00846832069408.

  • Brand
    Tornier
  • Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
  • 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
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
Recall numberProduct, codes & lots
Z-2019-2023AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101; GTIN 00846832069408, Serial Numbers: AZ1822082001, AZ1822082002, AZ1822082003, AZ1822082004, AZ1822082005, AZ1822082006, AZ1822082007, AZ1822082008, AZ1822082009, AZ1822082010, AZ1822082011, AZ1822082012, AZ1822082013, AZ1822082014, AZ1822082015, AZ1822082016, AZ1822082017, AZ1822082018, AZ1822082019, AZ1822082020, AZ1822082021, AZ1822082022, AZ1822082023, AZ1822082024, AZ1822082025, AZ1822082026, AZ1822082027, AZ1822082028, AZ1822082029, AZ1822082030, AZ1822082031, AZ1822082032, AZ1822082033, AZ1822082034, AZ1822082035, AZ1822082036, AZ1822082037, AZ1822082038, AZ1822082039, AZ1822082040, AZ1822082041, AZ1822082042, AZ1822082043, AZ1822082044, AZ1822082045, AZ1822082046, AZ1822082047, AZ1822082048, AZ1822082049, AZ1822082050, AZ1822082051, AZ1822082052, AZ1822082053, AZ1822082054, AZ1822082055
Z-2020-2023AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118; GTIN 00846832069408, Serial Numbers: AZ1322077001, AZ1322077002, AZ1322077003, AZ1322077004, AZ1322077005, AZ1322077006, AZ1322077007, AZ1322077008, AZ1322077009, AZ1322077010, AZ1322077011, AZ1322077012, AZ1322077013, AZ1322077014, AZ1322077015, AZ1322077016, AZ1322077017, AZ1322077018, AZ1322077019, AZ1322077020, AZ1322077021, AZ1322077022, AZ1322077023, AZ1322077024, AZ1322077025, AZ1322077026, AZ1322077027, AZ1322077028, AZ1322077029, AZ1322077030, AZ1322077031, AZ1322077032, AZ1322077033, AZ1322077034, AZ1322077035, AZ1322077036, AZ1322077037, AZ1322077038, AZ1322077039, AZ1322077040, AZ1322077041, AZ1322077042, AZ1322077043, AZ1322077044, AZ1322077045, AZ1322077046, AZ1322077047, AZ1322077048, AZ1322077049, AZ1322077050, AZ1322077051, AZ1322077052, AZ1322077053, AZ1322077054, AZ1322077055
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for model number ARS655118 and serial numbers starting with AZ1322077001 to AZ1322077055 on the screw packaging or label.

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 and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.” 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 published this recall 23 days after the firm started it.

1. Firm started the recall: Jun 12, 202312. FDA classified it Class II: Jun 28, 202323. Published in FDA’s Enforcement Report: Jul 5, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2020-2023 (June 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2020-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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