FDAClass IIOctober 6, 2021

Corin TriFit TS recall: Sterility Concern

Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.

Why was Corin TriFit TS recalled?

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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?

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 467870 was delivered to the consignee on 7/23/2021 and 7/26/2021.

Product
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Recalling firm
Corin Ltd
Quantity
5
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Recall date
October 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls