Zimmer Biomet recalls 16MM RapidFlap SpinDown Clamp (Ref 75-1030) due to incorrect assembly of the spin-down nut. This 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 because it was assembled incorrectly. This could cause improper bone flap reattachment during surgery, potentially leading to complications.
The spin-down nut that connects to the outer plate was assembled incorrectly. This could result in improper bone flap reattachment during surgery, which might cause complications like infection or misalignment.
Surgical teams using the Biomet Microfixation RapidFlap System 16MM SpinDown Clamp (Ref 75-1030) for bone flap reattachment after craniotomy. Patients undergoing this specific surgical procedure are at risk.
Look for the product name 'Biomet Microfixation RapidFlap System 16MM SpinDown Clamp' with reference number 75-1030. It was sold before the lot expiry date of 09/18/2023.
Verify the reference number on the product label to confirm it matches 75-1030.
The recall states the spin-down nut was assembled incorrectly, which could lead to improper bone flap reattachment during surgery. However, the remedy is not specified, so the risk level is low.
The recall does not specify a remedy, so no action is required. Check the product reference number to confirm if it matches 75-1030.
The product was sold before the lot expiry date of 09/18/2023.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0395-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0395-2019 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.