Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reus…

Recall date
December 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1044-2019
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US Distribution to OR and TN; and Internationally to: Japan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

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