FDA-Device2019-04-03Class II
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.
Smith & Nephew, Inc.
Hazard
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Sold states
US Distribution to OR and TN; and Internationally to: Japan.
Affected count
65 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2019Don't want to check this manually?
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