Date Initiated by Firm | December 10, 2018 |
Create Date | March 22, 2019 |
Recall Status1 |
Terminated 3 on November 03, 2020 |
Recall Number | Z-1042-2019 |
Recall Event ID |
81766 |
510(K)Number | K173331 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986
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: 17JGA0020; 17JGA0020A; 17JGA0020B; 17JGA0026; 17JGA0026A; 17JGA0026B; 17JGA0032A; 17JGA0032B; 17JGA0042; 17JGA0042A; 17JGA0042R |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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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 | 65 units |
Distribution | US Distribution to OR and TN; and Internationally to: Japan. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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