Depuy Ireland recalls BIOSTOP G Bioresorbable Cement Restrictors with higher endotoxin levels than FDA guidelines. These devices may cause inflammation or organ damage if used improperly.
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
Depuy Ireland is recalling BIOSTOP G Bioresorbable Cement Restrictors due to higher endotoxin levels than FDA standards. This could lead to inflammation or organ damage if the product is used in medical procedures.
Endotoxins in the product can trigger inflammatory responses, ranging from mild fever to potential damage to vital organs. The higher levels than FDA guidelines increase this risk during medical procedures.
Medical professionals using these devices during surgeries are most at risk. Patients receiving the product may experience inflammation or organ damage.
Check for catalog numbers: 546308000 (Size 8), 546310000 (Size 10), 546312000 (Size 12), 546314000 (Size 14), 546316000 (Size 16), 546318000 (Size 18), or 546320000 (Size 20). All lots from December 2022 through May 2025 are affected.
Identify the catalog number on the device to confirm if it is one of the recalled sizes (546308000 to 546320000).
Reach out to Depuy Ireland for further guidance on handling the recalled product.
The recalled BIOSTOP G Bioresorbable Cement Restrictors have higher endotoxin levels than FDA guidelines, which can cause inflammation or potential organ damage.
Check the catalog number on the device; recalled sizes include 546308000 (Size 8) through 546320000 (Size 20), all lots from December 2022 through May 2025.
Contact Depuy Ireland directly for instructions on handling the product, as no specific remedy is provided in the recall notice.
We’ve drafted a message you can send Depuy Ireland to request your refund or repair — edit it as you like.
Subject: Recall Z-0951-2023 — Depuy Ireland Depuy Ireland Hello, I own a Depuy Ireland that is covered by recall Z-0951-2023 from Depuy Ireland. 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.
