Tornier recalls Phantom Fiber sutures that may lose strength faster if improperly stored, potentially affecting surgical safety. Affected items include specific sizes and packaging. Consumers should check product details and contact Tornier for guidance.
Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
Tornier is recalling Phantom Fiber sutures that could lose strength more quickly if not stored properly. This might lead to weaker sutures during surgery, which could affect the safety of procedures.
The sutures may degrade faster if stored incorrectly, reducing their strength over time. This could lead to weaker sutures during surgery, potentially affecting the safety of procedures.
Surgical professionals and medical facilities using Tornier Phantom Fiber sutures are most at risk. Patients are not directly affected by this recall.
Check for item numbers like SMB000425, SMB000525, SMP000425, or SMSB0110 in the product packaging. The sutures are sold in specific sizes and packaging for general soft tissue procedures.
Look for item numbers such as SMB000425, SMB000525, SMP000425, or SMSB0110 on the packaging.
No, the recall does not require stopping use. The sutures may lose strength if stored improperly, but they are still safe to use if stored correctly.
Contact Tornier directly for guidance on proper storage and handling to ensure the sutures remain safe.
Patients are not directly affected by this recall. The issue relates to the sutures' storage and strength, not patient safety during procedures.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1374-2018 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1374-2018 from Tornier. 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.
