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U.S. Department of Health and Human Services

Class 2 Device Recall JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 78

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  Class 2 Device Recall JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 78 see related information
Date Initiated by Firm December 10, 2018
Create Date March 22, 2019
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-1045-2019
Recall Event ID 81766
510(K)Number K173331  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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.
Code Information Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Dave Snyder
978-749-1440
Manufacturer Reason
for Recall		 Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
FDA Determined
Cause 2		 Device Design
Action The firm, smith&nephew, initiated the recall by email with an "Urgent Medical Device Recall Notice" letter dated 12/10/18 to the customers on 12/10/2018. Letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -Inspect your inventory and locate any devices from the listed product and batch numbers and quarantine them immediately. - If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. -Complete and return the Response Form to FieldActions@smith-nephew.com or fax to 901-566-7975. Please Note  even if you have no product to return, this form must be completed, signed and returned. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce 46 units
Distribution US Distribution to OR and TN; and Internationally to: Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Smith & Nephew, Inc.
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