FDAClass IIOctober 25, 2023

stryker Tornier Perform Reversed Augmented Glenoid recall

stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Why was stryker Tornier Perform Reversed Augmented Glenoid recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 10846832062017, Lot Number 1756123

Product
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Recalling firm
Tornier, Inc
Quantity
30 units
Distribution
US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Recall date
October 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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