Lower risk Medical device recall · FDA · Published August 21, 2018

Exactech Equinoxe Reverse Drill Bit Kit Recall: Wrong Drill Bits for Shoulder Surgery

Exactech recalls Equinoxe Reverse Drill Bit Kit (Catalog 321-20-00) for shoulder surgery due to incorrect drill bit configuration. Affected units have serial numbers 5214432 and 5214445.

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

🇺🇸 FDA recall #Z-0012-2019Medical device Exactech ›

Lower-risk recall

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

Take action

Contact the company

Recalling firmExactech, Inc.2320 NW 66th Ct · Gainesville, FL 32653-1630

✎ GovInfoNow plain-language explainer

Exactech recalls a specific shoulder surgery drill bit kit because it contains two 2mm drill bits instead of one 2mm and one 3.2mm bit. This mismatch could cause surgical errors if used incorrectly. Read more at govinfonow.com/recall/70000-exactech-equinoxe-reverse-drill-bit-kit-recall-wrong-drill-bits.

Source Summary by GovInfoNow · govinfonow.com/recall/70000-exactech-equinoxe-reverse-drill-bit-kit-recall-wrong-drill-bits · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0012-2019

Cite this page

“Exactech Equinoxe Reverse Drill Bit Kit Recall: Wrong Drill Bits for Shoulder Surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70000-exactech-equinoxe-reverse-drill-bit-kit-recall-wrong-drill-bits. Based on FDA recall #Z-0012-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2019%22&limit=1).

The FDA announced on 2018-08-21 that Exactech, Inc. is voluntarily recalling the Equinoxe Reverse Drill Bit Kit due to a hazard involving incorrect drill bit quantities. The device is intended for shoulder surgery.

How to tell if you have it

Brand: Exactech
Product: Equinoxe Reverse Drill Bit Kit
Catalog Number: 321-20-00
Serial Numbers: 5214432, 5214445

The hazard

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended, according to the FDA.

Context

GovInfoNow's records show Exactech, Inc. has 34 other recalls on record since 2017-06-23. Recent brand recalls include the Equinoxe Ergo Ergo Modular Impactor Handle Recall on 2026-02-03 and the Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm recall on 2025-09-05. Other recent recalls of similar products include the Orthalign Drill Plate Recall (2026-02-10), the Tornier Perip Screw Recall (2025-12-19), and the Medline DEXLOCK Achilles Repair Kits recall (2025-11-11).

How to tell if you have this one

Check for the catalog number 321-20-00 on the kit. Affected units have serial numbers 5214432 and 5214445. The product is used for shoulder surgery procedures.

Brand
Exactech
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Serial Numbers
Look for serial numbers 5214432 or 5214445 on the kit packaging.

How this recall unfolded

Recall timeline

FDA published this recall 50 days after the firm started it.

Aug 21, 2018Firm started the recall
Oct 2, 2018FDA classified it Class II
Oct 10, 2018Published in FDA’s Enforcement Report

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

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Keep exploring

More Exactech recalls

Link to this recall

<a href="https://govinfonow.com/recall/70000-exactech-equinoxe-reverse-drill-bit-kit-recall-wrong-drill-bits">Exactech Equinoxe Reverse Drill Bit Kit Recall: Wrong Drill Bits for Shoulder Surgery (GovInfoNow)</a>

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-0012-2019 (August 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0012-2019 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.