Lower riskMedical device recall · FDA · Published December 15, 2020
DePuy Orthopaedics: Surgical Implants & Medical Devices
DePuy Orthopaedics is a leading manufacturer of surgical implants and medical devices for orthopedic procedures. Their products include joint replacements, spinal implants, and trauma devices.
Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
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Contact the company
📍Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
“DePuy Orthopaedics: Surgical Implants & Medical Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63658-depuy-orthopaedics-surgical-implants-medical-devices. Based on FDA recall #Z-0802-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0802-2021%22&limit=1).
The FDA has terminated a voluntary Class II recall initiated by DePuy Orthopaedics, Inc., involving specific lots of medical devices identified by serial numbers including 9578693, 9578065, and others.
How to tell if you have it
Product: Medical device components (specific lot numbers listed in facts)
Company: DePuy Orthopaedics, Inc.
Agency: FDA
Status: Terminated
The hazard
The original hazard for this specific lot was not explicitly stated in the provided facts; however, recent similar DePuy ATTUNE recalls have involved issues such as incorrect labeling, excessive radiation dose, corroded springs in sizing guides, and sterility risks in packaging.
Context
DePuy Orthopaedics, Inc. has a history of other recalls since July 12, 2017. Recent similar products recalled include Depuy ATTUNE Revision Hinge Femoral RT SZ 5 CEM, SZ 4 CEM, and SZ 3 CEM due to sterility risks in packaging (dated April 3, 2026). Previous recalls included ATTUNE Knee Component labeling errors (March 12, 2024), Attune Revision Limb Preservation Tibial Insert radiation dose issues (February 15, 2023), and ATTUNE Sizing Guide corroded springs (June 29, 2022).
How to tell if you have this one
Ensure that the surgical implants and medical devices are properly fitted and aligned, and that the patient follows post-operative care instructions.
Brand
DePuy Orthopaedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
1. Confirm the product's compatibility with your surgical procedure
Check with your surgeon to ensure that the DePuy Orthopaedics implant is appropriate for your specific condition and surgical needs.
2. Verify the product's proper installation
Ensure that the implant is correctly positioned and secured during surgery to minimize the risk of complications.
3. Follow post-operative care instructions
Adhere to the recommended recovery protocols and attend all follow-up appointments to monitor healing.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.9 years 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.
How do I know if a DePuy Orthopaedics implant is the right choice for me?
Your surgeon will determine the most appropriate implant based on your specific condition, bone structure, and surgical goals. They will consider factors such as the type of joint replacement, the patient's age, and overall health.
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-0802-2021 (December 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0802-2021 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.