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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