Orthofix recalls pelvis sterile kits with specific UDI numbers due to drill bits that may cause lower cutting performance. Affected kits require replacement.
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Orthofix is recalling pelvis sterile kits with a specific UDI number because some drill bits in the kit may not cut as intended. This could lead to less effective surgical procedures.
The drill bits in the recalled kits have a geometrical detail that doesn't match the intended design. This could cause lower cutting performance during surgical procedures, potentially leading to less effective outcomes.
Surgical professionals using Orthofix pelvis sterile kits with UDI (01)180S4242S11281 are most at risk. Patients receiving these kits during surgery may be affected.
Check for the UDI number (01)180S4242S11281 on the kit's packaging or label. The kit is sold under Orthofix Catalogue Number 99-93501US and was manufactured in Lot B1225391.
Look for the UDI number (01)180S4242S11281 on the kit's packaging or label.
The drill bits in the kit have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance during surgery.
Check for the UDI number (01)180S4242S11281 on the kit's packaging or label. The kit is sold under Orthofix Catalogue Number 99-93501US and was manufactured in Lot B1225391.
The recall record does not specify a remedy, so contact Orthofix directly for guidance.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0396-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0396-2020 from Orthofix. 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.
