Zimmer Biomet recalls 20MM RapidFlap SpinDown Clamps with incorrect assembly that could lead to improper bone flap reattachment after surgery.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Zimmer Biomet is recalling a specific surgical clamp used in brain surgery repairs. The clamp was assembled incorrectly, which could cause improper bone flap reattachment during surgery.
The spin-down nut interfaces with the outer plate incorrectly, which may cause improper bone flap reattachment. This could lead to complications during surgery if the clamp fails to hold the bone flap securely.
Surgical patients who received this specific clamp during bone flap reattachment procedures after a craniotomy. Surgeons and medical staff using this product are most at risk.
Check for the product name 'Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp' with reference number 75-1040. This product was sold before the lot expiry date of September 18, 2023.
Verify the reference number 75-1040 on the product label to confirm it is part of the recall.
The recall indicates the clamp was assembled incorrectly, which could lead to improper bone flap reattachment during surgery. However, the hazard level is low risk as the remedy does not require immediate discontinuation.
Look for the reference number 75-1040 on the product label. This product was sold before the lot expiry date of September 18, 2023.
The recall does not specify a remedy, so you should check with Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0397-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0397-2019 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.
