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Use caution Medical device recall · FDA · Published July 26, 2017

DeP: Concorde Lift Torque Handle Recall - Risk of Spinal Surgery Breakage

DePuy Orthopaedics recalls Concorde Lift Torque Limiting Handles used in spinal surgery. Potential for intra-operative breakage of driver tips could cause complications during spinal procedures.

🇺🇸 FDA recall #Z-0849-2018Medical deviceDePuy Orthopaedics ›
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Recalling firmDePuy Orthopaedics, Inc.325 Paramount Dr · Raynham, MA 02767-5199
✎ GovInfoNow plain-language explainer

What happened, in plain English

DePuy Orthopaedics is recalling Concorde Lift Torque Limiting Handles that are used with spinal fixation systems. These handles could break during surgery, potentially causing complications for patients. Read more at govinfonow.com/recall/73346-dep-concorde-lift-torque-handle-recall-risk-of-spinal-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/73346-dep-concorde-lift-torque-handle-recall-risk-of-spinal-surgery · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0849-2018

Cite this page

“DeP: Concorde Lift Torque Handle Recall - Risk of Spinal Surgery Breakage.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73346-dep-concorde-lift-torque-handle-recall-risk-of-spinal-surgery. Based on FDA recall #Z-0849-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0849-2018%22&limit=1).

Why it’s dangerous

The handle could break during spinal surgery when used with certain internal spinal fixation systems. This breakage might cause complications like delayed healing or additional surgery.

Who’s affected

Surgical teams using these handles during spinal procedures are most at risk. Patients undergoing spinal surgery with this specific handle may be affected.

How to tell if you have this one

Check for product code 287804102 with lot numbers 122315-B R, 122315-A R, or 041117A. These handles are used with spinal fixation systems cleared for lumbar spine procedures.

  • Brand
    DePuy Orthopaedics
  • 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
    Nationwide Distribution
Recall numberProduct, codes & lots
Z-0848-2018Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.; Product code: 287804101G Lot number: 052316-A R, 121416-A R
Z-0849-2018Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.; Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A
Based on the official FDA remedy

What to do — step by step

  1. Check Handle Lot Number

    Look for lot numbers 122315-B R, 122315-A R, or 041117A on the handle packaging or label.

Where it went and when

Where it was distributed

Distributed nationwide.

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: “Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jul 26, 201712. FDA classified it Class II: Mar 2, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Apr 3, 2019420172019
  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-0849-2018 (July 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0849-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 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