FDAClass IIApril 3, 2019

Journey II XR Tibial Posterior Keel Punch SZ 7-8 recall

JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used…

Why was Journey II XR Tibial Posterior Keel Punch SZ 7-8 recalled?

Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

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?

Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R

Product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used…
Recalling firm
Smith & Nephew, Inc.
Quantity
46 units
Distribution
US Distribution to OR and TN; and Internationally to: Japan.
Recall date
April 3, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls