FDAClass IIOctober 9, 2024

Stryker Tornier Perform Humeral System recall

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Why was Stryker Tornier Perform Humeral System recalled?

Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

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?

GTIN 00846832084494, Batch Lot # 1495AY

Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Recalling firm
Tornier, Inc
Quantity
38 units
Distribution
US Nationwide distribution.
Recall date
October 9, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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