DeP: Universal Femoral Sleeves Recall - Taper Dimensions May Be Out of Specification
DePuy recalls Universal Femoral Sleeves used in revision knee surgeries due to potential taper dimension issues from manufacturing. Affected lots include J85Y90, J86T23, J86T20, J8790J, J85Y92. Contact for details.
Lower-risk recall
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Contact the company
What happened, in plain English
DePuy recalls certain Universal Femoral Sleeves used in revision knee surgeries because their taper dimensions might be out of specification due to a manufacturing issue. This could affect the safety of the surgical procedure if the sleeves don't fit properly. Read more at govinfonow.com/recall/63439-dep-universal-femoral-sleeves-recall-taper-dimensions-may-be-out.
Source Summary by GovInfoNow · govinfonow.com/recall/63439-dep-universal-femoral-sleeves-recall-taper-dimensions-may-be-out · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1103-2021
Cite this page
“DeP: Universal Femoral Sleeves Recall - Taper Dimensions May Be Out of Specification.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63439-dep-universal-femoral-sleeves-recall-taper-dimensions-may-be-out. Based on FDA recall #Z-1103-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1103-2021%22&limit=1).
Why it’s dangerous
The taper dimensions of the sleeves may be out of specification due to a manufacturing issue. This could lead to improper fitting during revision knee surgeries, potentially affecting surgical outcomes.
Who’s affected
Surgical teams using these sleeves in revision knee surgeries are most at risk. Patients receiving these sleeves during the specified production lots are affected.
How to tell if you have this one
Check the lot numbers: J85Y90, J86T23, J86T20, J8790J, or J85Y92. These sleeves are used with S-ROM Noiles, LPS, SIGMA, and LCS knee products in revision surgeries.
- Brand
DePuy- Category
Medical device
What to do — step by step
Check Lot Numbers
Look for lot numbers J85Y90, J86T23, J86T20, J8790J, or J85Y92 on the sleeves.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, Florida, Indiana, Michigan, Minnesota, Mississippi, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Virginia.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1103-2021 (January 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1103-2021 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.