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Lower risk Medical device recall · FDA · Published September 9, 2021

DePuy ATTUNE Revision Tibial Augment Size 7/8 5mm Recall: Surgery Delay Risk

DePuy recalls knee replacement implants with part code 152307001 due to potential surgery delays from improper screws. Affected units sold between 2020-2022.

🇺🇸 FDA recall #Z-0074-2022Medical deviceDePuy ›
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Contact the company

Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
✎ GovInfoNow plain-language explainer

DePuy is recalling knee joint replacement implants that may include screws not designed for use with the 5mm augments, which could delay surgery. This recall affects patients who received the specific implant model. Read more at govinfonow.com/recall/61816-depuy-attune-revision-tibial-augment-size-7-8-5mm-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/61816-depuy-attune-revision-tibial-augment-size-7-8-5mm-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0074-2022

Cite this page

“DePuy ATTUNE Revision Tibial Augment Size 7/8 5mm Recall: Surgery Delay Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61816-depuy-attune-revision-tibial-augment-size-7-8-5mm-recall. Based on FDA recall #Z-0074-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2022%22&limit=1).

The FDA announced on Sept. 9, 2021, that DePuy Orthopaedics, Inc. is recalling ATTUNE Revision Tibial Augment Size 7/8 5mm knee joint replacement parts due to packaging errors. The hazard involves unintended screws that may cause surgical delays. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: DePuy
  • Product: ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
  • UPC: 10603295057642
  • Lot Number: J6304Z

The hazard

The packaging may include screws that are not intended to be used with the 5mm augments, which may cause delay in surgery.

Context

GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since July 12, 2017. Other recent recalls of similar products include DePuy Orthopaedics Recalls ATTUNE Knee Component Due to Incorrect Labeling (March 12, 2024), DePuy Attune Revision Limb Preservation System Tibial Insert Recall: Radiation Dose Risk (Feb. 15, 2023), and DePuy ATTUNE Sizing Guide Recall: Corroded Spring Risks Surgical Complications (June 29, 2022).

How to tell if you have this one

Check for part code 152307001 on the implant packaging. The recall covers units sold between 2020 and 2022 with lot number J6304Z.

  • Brand
    DePuy
  • Product
    ATTUNE Revision Tibial Augment Size 7/8 5mm
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Packaging

    Look for part code 152307001 on the packaging to confirm if your implant is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Louisiana, Minnesota, Missouri, Nebraska, North Carolina, Oregon, Pennsylvania, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Sep 9, 202112. FDA classified it Class II: Oct 7, 202123. Published in FDA’s Enforcement Report: Oct 13, 202134. FDA terminated the recall: Aug 9, 2023420212023
  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.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury?

The recall addresses potential surgery delays, not direct injury risks. The hazard is not severe enough to require immediate stop-use.

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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-0074-2022 (September 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0074-2022 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