Synthes recalls trial spacers with T-handle that were modified outside approved manufacturing. These devices may not function as intended due to improper production.
Modified outside of approved manufacturing process
Synthes is recalling trial spacers (7mm to 17mm with T-handle) that were modified during manufacturing. This could cause them to not work properly, potentially leading to incorrect surgical outcomes.
The spacers were made outside approved manufacturing processes, which could result in improper dimensions or functionality. This might cause the devices to not fit correctly during surgery, potentially leading to complications.
Surgical professionals using these trial spacers for orthopedic procedures are most at risk. Patients who have received these devices may also be affected.
Check for trial spacers with T-handle and sizes from 7mm to 17mm. These were sold under the brand Synthes with unknown manufacturing details.
Identify if your spacer has a T-handle and size between 7mm and 17mm.
The recall states they were modified outside approved manufacturing, which could affect function but does not specify injury risk.
Look for trial spacers with T-handle and sizes from 7mm to 17mm sold by Synthes.
The recall does not provide a specific remedy, so contact Synthes directly for guidance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0349-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0349-2020 from Synthes. 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.
