medical Class II Updated 2019-04-03

Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013

Recalled Product

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.

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: 17JGA0022; 17JGA0022A; 17JGA0022B; 17JGA0028; 17JGA0028A; 17JGA0028B; 17JGA0034A; 17JGA0034C; 17JGA0044; 17JGA0044B; 17JGA0044R; 18BGA0015A & 18BGA0015B
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