FDAClass IIMay 5, 2021

CANNU-Flex SILK Interference Screws 6 mmx 30 mm recall: Labeling Error

CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior…

Why was CANNU-Flex SILK Interference Screws 6 mmx 30 mm recalled?

Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw

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: 50906647

Product
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior…
Recalling firm
Smith & Nephew, Inc.
Quantity
2 units US and 193 units OUS. 195 units WW
Distribution
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
Recall date
May 5, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls