DePuy Orthopaedics recalls cementless femoral stems labeled Size 11 but actually Size 12. This mismatch risks poor joint fit, loosening, and extra surgery. Affected units sold between 2018-2020.
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Take action
Contact the company
📍Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
“DePuy CORAIL Femoral Stem Size 11 Mislabeled as Size 12 - Recall.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70790-depuy-corail-femoral-stem-size-11-mislabeled-as-size-12. Based on FDA recall #Z-2521-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2521-2018%22&limit=1).
The FDA announced on June 21, 2018, that DePuy Orthopaedics, Inc. recalled CORAIL Cementless Femoral Stem HA Coated Standard Size 11 units due to mislabeling hazards. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: DePuy Orthopaedics
Product: CORAIL Cementless Femoral Stem HA Coated Standard Size 11
Catalog No.: 3L92511
Lot codes: 5307603, 5300997
The hazard
Two lots of femoral stems labeled as Size 11 were actually Size 12. The FDA stated this error could cause poor joint mechanics, improper fit, loosening, intraoperative fracture, and require additional surgical procedures to correct.
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 ATTUNE Knee Component Due to Incorrect Labeling (March 12, 2024), ATTUNE Revision Limb Preservation Tibial Insert Recall (February 15, 2023), and EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (February 16, 2026).
How to tell if you have this one
Check if your implant has the catalog number 3L92511 or the serial numbers 5307603 or 5300997. These units were sold between 2018 and 2020.
Brand
DePuy Orthopaedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Your Surgeon
Your surgeon can confirm if you have the recalled implant and provide next steps.
Where it went and when
Where it was distributed
Distributed in 14 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Colorado, Georgia, Illinois, Louisiana, Maine, New Hampshire, New York, North Carolina, Oregon, Texas, Utah, Washington.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2521-2018 (June 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2521-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.