Signature Orthopaedics Europe Ltd recalls Encina HA Femoral Stem (Size 11) due to mislabeled packaging causing surgical delays. Affected patients should contact the manufacturer for details.
The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.
Signature Orthopaedics is recalling a specific hip replacement stem because its packaging is mislabeled. This could lead to surgical delays if the wrong product is used during surgery.
The packaging contains incorrect product labels, which might lead to using the wrong hip replacement component during surgery. This could cause delays in the surgical procedure if the wrong product is selected.
Patients scheduled for hip replacement surgery using this specific stem model are affected. Surgeons and hospitals using the product are most at risk of delays.
Check for the model: Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V with HA Coating. The product is part of Stinson Orthopedics Inc.'s Total Hip Replacement System.
Reach out to Signature Orthopaedics Europe Ltd for specific guidance on the recall and next steps.
The packaging is mislabeled, which could result in using the wrong hip replacement component during surgery, causing surgical delays.
Contact Signature Orthopaedics Europe Ltd directly for specific instructions as there is no stated remedy.
The recall is for potential surgical delays, not direct injury risks. The hazard does not involve immediate safety threats.
We’ve drafted a message you can send Signature Orthopaedics to request your refund or repair — edit it as you like.
Subject: Recall Z-1568-2020 — Signature Orthopaedics Signature Orthopaedics Hello, I own a Signature Orthopaedics that is covered by recall Z-1568-2020 from Signature Orthopaedics. 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.