DeRoyal recalls posterior lumbosacral fusion packs with specific lot numbers due to potential serious injury risk. Affected units include lots 56395179, 56431133, 57190554, and 5740754.
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DeRoyal is recalling posterior lumbosacral fusion packs with specific lot numbers because they may cause serious injury. This recall affects patients who have received these implants and requires immediate action to prevent harm.
The recall is due to a potential risk of serious injury from improper implant placement or failure of the fusion pack during surgery. This could lead to complications such as infection, nerve damage, or failure of spinal fusion.
Patients who received DeRoyal posterior lumbosacral fusion packs with the listed lot numbers are most at risk. Healthcare providers who use these products for surgical implants should also check their inventory.
Check the lot number on the packaging of your DeRoyal posterior lumbosacral fusion pack. The affected lots are 56395179 (expires 12/1/2023), 56431133 (expires 9/1/2023), 57190554 (expires 3/1/2024), and 5740754 (expires 4/1/2024).
Immediately stop using the recalled DeRoyal posterior lumbosacral fusion packs with the listed lot numbers to prevent potential serious injury.
The affected lot numbers are 56395179 (expires 12/1/2023), 56431133 (expires 9/1/2023), 57190554 (expires 3/1/2024), and 5740754 (expires 4/1/2024).
The recall is due to a potential risk of serious injury from improper implant placement or failure of the fusion pack during surgery.
The official recall notice does not specify contact information for further assistance.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0670-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0670-2023 from DeRoyal. 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.
