medical Class II Updated 2019-04-03

Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013

Recalled Product

JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 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.

Hazard / Issue

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

Issued by

FDA

Affected States: OR, TN
Lot/Code Info: Batch Numbers: 17JGA0020; 17JGA0020A; 17JGA0020B; 17JGA0026; 17JGA0026A; 17JGA0026B; 17JGA0032A; 17JGA0032B; 17JGA0042; 17JGA0042A; 17JGA0042R
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