Use cautionMedical device recall · FDA · Published December 20, 2017
Integra Humeral Stem Trials Recall: Risk of Breakage During Surgery
Integra LifeSciences recalls humeral stem trials for Titan Modular Shoulder System due to reported breakage during insertion or extraction, causing delays in surgery. Affected items include specific catalog numbers and lot numbers.
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
Take action
Contact the company
📍Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr · Plainsboro, NJ 08536-3344
“Integra Humeral Stem Trials Recall: Risk of Breakage During Surgery.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72256-integra-humeral-stem-trials-recall-risk-of-breakage-during-surgery. Based on FDA recall #Z-1463-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1463-2018%22&limit=1).
Integra LifeSciences Corp. recalled humeral stem trials for the Titan Modular Shoulder System due to breakage hazards, according to the FDA on December 20, 2017. The agency announced the Class II recall of 1,619 units distributed worldwide.
How to tell if you have it
Brand: Integra LifeSciences
Product: Humeral Stem Trial (TRL092002506 through TRL092002516)
Lot Numbers: 19419-1 through 19419-11, 15916-1 through 15916-11, 15457-1 through 15457-11, 201274-1 through 201274-11, 201893-1 through 201893-11, 2046177 through 20461717
Units: 1,619
The hazard
Incidents of stem trial breakage were reported during insertion or extraction while preparing the humeral canal. All cases resulted in a delay in surgery with varying medical intervention required.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since August 18, 2017. Recent brand recalls include the AURORA Surgiscope System recall (February 6, 2025) and the MediHoney Wound Dressing Gel recall (January 10, 2025). Other recent recalls of similar products include the Zimmer Off-Axis Shoulder System Recall (May 20, 2026) and the Medacta Short Monobloc Stem Broaches Risk of Shoulder Fracture During Surgery (April 30, 2026).
How to tell if you have this one
Check for catalog numbers TRL092002506 to TRL092002516 on the packaging. Affected items include specific lot numbers listed in the recall notice.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the catalog number and lot numbers on the packaging to determine if your item is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - USA (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 2.2 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.
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-1463-2018 (December 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1463-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.