DePuy recalls P.F.C. SIGMA Revision Knee System Distal Augment Model 960830 due to potential missing screw/collet assembly. Affected units may require repair or replacement.
This unit may be missing the screw/collet Assembly
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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 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. Read more at govinfonow.com/recall/70419-depuy-p-f-c-sigma-revision-knee-system-distal-augment.
“DePuy P.F.C. SIGMA Revision Knee System Distal Augment Recall: Missing Screw Assembly.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70419-depuy-p-f-c-sigma-revision-knee-system-distal-augment. Based on FDA recall #Z-2949-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2949-2018%22&limit=1).
DePuy Orthopaedics, Inc. recalled P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830, due to a potential missing screw/collet assembly, the FDA said on July 18, 2018. The devices were distributed to Great Britain and are not sold in the United States.
How to tell if you have it
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Lot: C2KJ24
GTIN: 10603295234135
The hazard
The recall notice states the unit may be missing the screw/collet Assembly. The FDA classified this as a Class II recall.
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 ATTUNE Sizing Guide Recall (June 29, 2022).
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
Product
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
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.
How this recall unfolded
Recall timeline
FDA terminated this recall 9 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-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.