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JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Poste...

FDA Recall #Z-1043-2019 — Class II — December 10, 2018

Recall #Z-1043-2019 Date: December 10, 2018 Classification: Class II Status: Terminated

Product Description

JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 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.

Reason for Recall

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

Recalling Firm

Smith & Nephew, Inc. — Memphis, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

65 units

Distribution

US Distribution to OR and TN; and Internationally to: Japan.

Code Information

Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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