| Class 2 Device Recall JOURNEY II BCS | |
Date Initiated by Firm | September 27, 2023 |
Date Posted | October 24, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0158-2024 |
Recall Event ID |
93156 |
510(K)Number | K111711 K140555 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis |
Code Information |
UDI/DI 00885556176467, Batch Number 22BM17564 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact | David Snyder 978-749-1440 |
Manufacturer Reason for Recall | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM. |
FDA Determined Cause 2 | Component change control |
Action | Smith & Nephew, Inc. issued an Urgent Medical Device Recall Notice to its consignees on 09/27/2023 via email and overnight mail. The notice explain the issue, potential risk, and requested the following actions:
Inspect inventory, locate, and quarantine the affected devices.
Sales representatives, district offices, or distributors were directed to notify their customers
The firm is seeking return of unused products. |
Quantity in Commerce | 29 units |
Distribution | Worldwide distribution - US Nationwide and the country of 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JWH
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