Stryker recalls certain Femoral Nails (R1500 T2 Femur 12x300mm) due to potential reduced strength causing premature breakage. Affected products have specific product numbers and lot codes.
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Stryker is recalling certain femoral nails that may have weaker strength due to manufacturing issues, which could lead to premature breakage during use. This poses a risk to patients undergoing surgery who might experience complications from a broken nail.
The nails may have been produced with specifications that don't meet quality standards, leading to reduced strength. This could cause the nails to break prematurely during surgical procedures, potentially causing complications for patients.
Patients who have received the recalled femoral nails during surgery are most at risk. Medical professionals using these specific nails in procedures may also be affected.
Check for the product number 18281230S, lot code K07AFF5, or the GTIN 04546540200655 on the nail packaging. These items were sold with the specific model and size mentioned in the recall.
Look for the product number 18281230S, lot code K07AFF5, or GTIN 04546540200655 on the nail packaging to confirm if it is affected.
The manufacturer discovered that some products may have left the factory with specifications that don't meet quality standards, which could lead to reduced strength and premature breakage.
The recall does not include a specific remedy, so check the product details to see if it matches the affected items and contact Stryker for further guidance.
The recall states potential premature breakage, but no specific mention of serious injury. The danger level is low risk due to the nature of the issue being a manufacturing defect rather than an immediate hazard.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2399-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2399-2018 from Stryker. 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.
