FDAClass IIMarch 13, 2019

Instrument Tray recall

Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty

Why was Instrument Tray recalled?

The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)

Product
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Recalling firm
Stryker GmbH
Quantity
17 units
Distribution
In the countries of Canada and Korea
Recall date
March 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls