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.
Integra LifeSciences is recalling humeral stem trials used in shoulder surgery because they have broken during insertion or extraction, causing delays in surgery. This recall affects specific sizes and lot numbers of the trials.
The humeral stem trials can break during insertion or extraction from the humeral canal, which delays surgery and requires additional medical intervention. This breakage has been reported in incidents but does not cause immediate injury.
Surgical teams using the Titan Modular Shoulder System with the recalled humeral stem trials are affected. Patients scheduled for shoulder surgery using these specific models may be at risk of delayed procedures.
Check for catalog numbers TRL092002506 to TRL092002516 on the packaging. Affected items include specific lot numbers listed in the recall notice.
Review the catalog number and lot numbers on the packaging to determine if your item is affected.
The recall is due to reported incidents of humeral stem trials breaking during insertion or extraction, causing delays in surgery.
Check the catalog number and lot numbers on the packaging to see if your item is affected. If it is, contact Integra LifeSciences for further instructions.
The recall record states that all incidents resulted in a delay in surgery but does not mention injuries.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1463-2018 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1463-2018 from Integra LifeSciences. 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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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.
