DePuy P.F.C. SIGMA Revision Knee System Distal Augment Recall: Missing Screw Assembly

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Contact the company & request your remedy

Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr, N/A · Warsaw, IN 46582-3994

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

DePuy is recalling a specific knee replacement model because it might be missing a critical screw or collet assembly. This could lead to improper function or failure of the joint. Affected customers should check their product details and follow the recall instructions.

Why it’s dangerous

The knee system might be missing a screw or collet assembly, which is a critical component for proper joint function. Without this part, the implant could become unstable or fail during use.

Who’s affected

People who own or use the DePuy P.F.C. SIGMA Revision Knee System Distal Augment with model number 960830 are affected. Those with the specific lot number C2KJ24 are at higher risk.

How to tell if you have this one

Check for the model number 960830 on the product packaging or label. The affected lot number is C2KJ24, and the GTIN is 10603295234135.

Brand
DePuy
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number 960830 and lot number C2KJ24 on the product packaging or label.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is for a potential missing screw/collet assembly, which could affect joint function but does not pose an immediate risk of serious injury.

How do I know if my product is affected?

Check for model number 960830 and lot number C2KJ24 on the product packaging or label.

What should I do if I have this product?

The recall does not specify a remedy, so contact DePuy directly for further instructions.

Take action

Contact DePuy

We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2949-2018 — DePuy DePuy

Hello,

I own a DePuy that is covered by recall Z-2949-2018 from DePuy.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2949-2018 (July 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2949-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 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.

DePuy Orthopaedics, Inc. recalls P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

Lower-risk recall