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Lower risk Medical device recall · FDA · Published May 18, 2022

Paragon 28 Baby Gorilla Drill Recall: Incorrect Part Number Labeling

Paragon 28 recalls Baby Gorilla/Gorilla Plating System (Ref: P99-100-2816) due to potential incorrect part numbers in drill packaging. Affected units may have wrong labels.

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

🇺🇸 FDA recall #Z-1458-2022Medical deviceParagon 28 ›
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Contact the company

Recalling firmParagon 28, Inc.14445 Grasslands Dr · Englewood, CO 80112-7062
✎ GovInfoNow plain-language explainer

Paragon 28 is recalling their Baby Gorilla/Gorilla Plating System drills because the packaging might have the wrong part number. This could lead to using the wrong drill part, but it doesn't pose a safety risk. Read more at govinfonow.com/recall/60696-paragon-28-baby-gorilla-drill-recall-incorrect-part-number-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/60696-paragon-28-baby-gorilla-drill-recall-incorrect-part-number-labeling · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1458-2022

Cite this page

“Paragon 28 Baby Gorilla Drill Recall: Incorrect Part Number Labeling.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60696-paragon-28-baby-gorilla-drill-recall-incorrect-part-number-labeling. Based on FDA recall #Z-1458-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1458-2022%22&limit=1).

The FDA announced on May 18, 2022, that Paragon 28, Inc. is recalling its Baby Gorilla/Gorilla Plating System drills due to incorrect labeling. The hazard stems from packaging that may contain an incorrect part number. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Paragon 28
  • Product: Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System
  • Ref: P99-100-2816
  • Material: Stainless Steel
  • Description: Drill, 2.4 X 160mm
  • Lot #: HN2204123455
  • UDI/DI: 00889795053329
  • Quantity: 3 units
  • Distribution: International distribution in the country of UK

The hazard

According to the FDA, there is a potential that the drill packaging contains the incorrect part number. This labeling error constitutes the primary hazard for this Class II recall.

Context

GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since 2017-12-19. Other recent recalls of similar products include Smith & Nephew BIOSURE HA Screw Recall (2025-11-24) and Tornier Perip Screw Recall (2025-12-19).

How to tell if you have this one

Check if your drill has the model number P99-100-2816 and the lot number HN2204123455. The product is a stainless steel drill measuring 2.4 x 160mm.

  • Brand
    Paragon 28
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Labels

    Verify the part number on the drill packaging matches the correct model number P99-100-2816.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: May 18, 202212. FDA classified it Class II: Jul 25, 202223. Published in FDA’s Enforcement Report: Aug 3, 202232022
  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-1458-2022 (May 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1458-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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