medical Class II Updated 2019-04-03

Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013

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