New Standard Device Inc recalls Metalogix Self-Drill Half-Pins due to reported tip breakages during surgery. Affected models include 5x30x215mm, 5x40x215mm, 5x60x215mm, and 5x80x215mm with specific lot numbers.
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in orthopedic surgery because they have broken during procedures. This could lead to complications if the pins fail while setting up a patient's external fixation system.
The pins can break during surgery, which may cause complications in the patient's treatment. This breakage could lead to the need for additional procedures or delays in healing.
Orthopedic surgeons and medical staff who use the Metalogix Self-Drill Half-Pins in surgery are most at risk. Patients receiving external fixation treatments may also be affected if the pins break during procedures.
Check for the model numbers: 5x30x215mm (REF 620030), 5x40x215mm (REF 620040), 5x60x215mm (REF 620060), or 5x80x215mm (REF 620080). Also look for lot numbers A29418X, A17219CA, A29418Y, A17219CB, A29418Z, A17219CC, A29518A, or A17219CD.
Verify the model number and lot numbers listed in the recall notice to confirm if your item is affected.
Reach out to New Standard Device Inc for guidance on next steps if your item is recalled.
The recall is due to complaints about Self-Drill Half-Pin tip breakages occurring during surgery.
The affected models are 5x30x215mm (REF 620030), 5x40x215mm (REF 620040), 5x60x215mm (REF 620060), and 5x80x215mm (REF 620080).
Check for the specific model numbers and lot numbers listed in the recall notice.
We’ve drafted a message you can send Metalogix Self-Drill to request your refund or repair — edit it as you like.
Subject: Recall Z-1649-2022 — Metalogix Self-Drill Metalogix Self-Drill Hello, I own a Metalogix Self-Drill that is covered by recall Z-1649-2022 from Metalogix Self-Drill. 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.
