Tornier recalls specific 25mm Perform Reversed Augmented Glenoid Lateralized Baseplates with 6mm spacers instead of 3mm, preventing screw threading. Affected units have UDI 10846832062017 and Lot 1756123.
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
Tornier is recalling a specific type of surgical baseplate that was made with 6mm spacers instead of the required 3mm spacers. This defect prevents the central screw from threading properly, which could lead to improper surgical fixation.
The baseplate was manufactured with 6mm spacers instead of the required 3mm spacers. This causes the central screw to be unable to thread into the baseplate, which may lead to improper surgical fixation during procedures.
Surgical professionals who purchased or use the specific Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate model with UDI 10846832062017 and Lot 1756123 are affected. The risk is low as this is a manufacturing error that does not cause immediate harm.
Check for the product name 'Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate', 25mm, Offset +3mm, REF DWJ502. Affected units have UDI 10846832062017 and Lot Number 1756123.
Verify the product's UDI 10846832062017 and Lot Number 1756123 to confirm if it is affected.
The baseplate was manufactured with 6mm spacers instead of the required 3mm spacers, which prevents the central screw from threading properly.
Check for the UDI 10846832062017 and Lot Number 1756123 on the product label.
The recall does not specify a remedy, so no action is required beyond checking if your product matches the affected details.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-0113-2024 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-0113-2024 from Tornier. 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.