Zimmer Biomet recalls 12mm SpinDown Clamps with incorrect assembly that may cause improper bone flap reattachment after surgery. Affected units have sterile Ref Number 75-1020 and expiry before 09/18/2023.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Zimmer Biomet is recalling a specific surgical clamp that was assembled incorrectly. This could lead to improper bone flap reattachment after brain surgery if used without correction.
The clamp's spin-down nut interfaces with the outer plate incorrectly. This could cause improper bone flap reattachment after brain surgery if used without correction, potentially leading to complications.
Surgical patients who received this specific clamp during craniotomy procedures. Surgeons using the product for bone flap reattachment are most at risk of complications.
Check for sterile Ref Number 75-1020 on the clamp. The product was sold before September 18, 2023, with an expiry date before that date.
Look for sterile Ref Number 75-1020 on the clamp.
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp with sterile Ref Number 75-1020.
The spin-down nut interfaces with the outer plate incorrectly, which could cause improper bone flap reattachment after brain surgery.
Check for sterile Ref Number 75-1020 on the clamp. The product was sold before September 18, 2023, with an expiry date before that date.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0393-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0393-2019 from Zimmer Biomet. 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.