Orthofix recalls Galaxy Wrist Sterile Kit (catalog #99-93601) with specific lot numbers due to drill bits that may cause lower cutting performance. Affected users should check their kit's UDI and lot numbers.
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 Galaxy Wrist Sterile Kits with certain lot numbers because the drill bits may not cut as intended. This could lead to less effective use of the kit during procedures.
The drill bits in the recalled batches have a geometrical detail that doesn't match the intended design. This could result in lower cutting performance, meaning the kit might not function as expected during procedures.
Users of the Galaxy Wrist Sterile Kit with specific lot numbers (81213075, 81215044, 81216539, 81217847, 81234691) are affected. Medical professionals using these kits for procedures are most at risk.
Check the kit's Unique Device Identifier (UDI) and lot numbers: UDI (01)18054242511656 and lot numbers 81213075, 81215044, 81216539, 81217847, 81234691.
Verify your Galaxy Wrist Sterile Kit's UDI (01)18054242511656 and lot numbers against the listed numbers.
The drill bits in these batches have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance.
Check your kit's UDI and lot numbers to see if it's affected. If it is, contact Orthofix for further instructions.
The recall is due to potential lower cutting performance, not immediate safety risks like injury or fire.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0403-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0403-2020 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.
