Wishbone Medical recalls specific plate and screw systems due to engineering nonconformities. Affected products include certain part numbers and lot numbers. Consumers should check their items against the list provided.
Nonconformities were discovered to the engineering specifications for implant plates and screws.
Wishbone Medical is recalling specific plate and screw systems that do not meet engineering specifications. This could lead to improper bone fixation and potential complications during surgery.
The recalled components do not meet engineering specifications, which could result in improper bone fixation during surgery. This might lead to complications such as delayed healing or the need for additional surgical interventions.
Patients who have received the recalled implant components during surgery are most at risk. The recall applies to specific part numbers and lot numbers used in medical procedures.
Check the part numbers: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US. Lot numbers listed in the recall include 20837, 124555, and other specific numbers. These items were sold to medical facilities for surgical use.
Review the part numbers and lot numbers on your implant components to see if they match the recalled list.
The affected part numbers are PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, and PK-SMC0835NSR-TI-US.
Lot numbers include 20837, 124555, 124557, 124558, and other specific numbers listed in the recall notice.
The recall does not specify a remedy, so no action is required if you have the items. However, you should check your product details to confirm if they are affected.
We’ve drafted a message you can send Wishbone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1794-2021 — Wishbone Medical Wishbone Medical Hello, I own a Wishbone Medical that is covered by recall Z-1794-2021 from Wishbone Medical. 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.
