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Use caution Medical device recall · FDA · Published April 11, 2023

Integra Codman Cranial Hand Drill Recall: Rust Risk Causes Inflammation

Integra LifeSciences recalls Codman Cranial Hand Drills with rust in drill chuck that may cause inflammation, infection, or surgery delays. Affected units have specific part numbers and lot numbers.

🇺🇸 FDA recall #Z-1614-2023Medical deviceIntegra LifeSciences ›
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Recalling firmIntegra LifeSciences Corp.1100 Campus Rd · Princeton, NJ 08540-6650
✎ GovInfoNow plain-language explainer

Integra LifeSc: Recalls Codman Cranial Hand Drills that may have rust in the drill chuck. This rust can cause inflammation, infection, or require revision surgery. Affected units have specific part numbers and lot numbers. Read more at govinfonow.com/recall/58589-integra-codman-cranial-hand-drill-recall-rust-risk-causes-inflammation.

Source Summary by GovInfoNow · govinfonow.com/recall/58589-integra-codman-cranial-hand-drill-recall-rust-risk-causes-inflammation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1614-2023

Cite this page

“Integra Codman Cranial Hand Drill Recall: Rust Risk Causes Inflammation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58589-integra-codman-cranial-hand-drill-recall-rust-risk-causes-inflammation. Based on FDA recall #Z-1614-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1614-2023%22&limit=1).

Integra LifeSciences Corp. voluntarily recalled Codman Cranial Hand Drills on April 11, 2023, according to the FDA. The devices may have rusted chucks that could cause toxicity or infection.

How to tell if you have it

  • Brand: Integra LifeSciences
  • Product: Codman Cranial Hand Drill
  • Part Number: 82-6607
  • UDI-DI: 10381780520337
  • Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710
  • Units affected: 337

The hazard

The Codman Cranial Hand Drill may be released with discoloration or rust on the drill chuck and inner chuck. This defect may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to users, and/or infection.

Context

GovInfoNow's records show Integra LifeSciences Corp. has had 35 other recalls since August 18, 2017. Recent brand recalls include the AURORA Surgiscope System on February 6, 2025, and MediHoney Wound Dressing Gel on January 10, 2025. Other recent recalls of similar products include Integra Cytal Wound Matrix 2-Layer (March 19, 2026), Smith & Nephew TRIGEN Humeral Nail (March 16, 2026), and Orthalign Drill Plate (February 10, 2026).

How to tell if you have this one

Check for part number 82-6607 or lot numbers 6808685, 6563961, 6568711, 6568709, 6568710 on the drill. The device is used for craniotomy procedures to place intracranial pressure monitoring devices.

  • Brand
    Integra LifeSciences
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Rust

    Inspect the drill chuck for discoloration (rust) as this may cause inflammation or infection.

  2. Contact Manufacturer

    Reach out to Integra LifeSciences for specific guidance on affected units.

Where it went and when

Where it was distributed

Distributed in Pennsylvania, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “PA Foreign: Australia, Belgium” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Pennsylvania.

Recall timeline

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

1. Firm started the recall: Apr 11, 202312. FDA classified it Class II: May 19, 202323. Published in FDA’s Enforcement Report: May 31, 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-1614-2023 (April 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1614-2023 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