| Class 2 Device Recall Smith & Nephew Genesis II | |
Date Initiated by Firm | October 02, 2024 |
Date Posted | October 31, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0281-2025 |
Recall Event ID |
95494 |
510(K)Number | K962557 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic |
Code Information |
UDI/DI 03596010469212, Batch number 23LM02331 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 6409 E Holmes Rd Memphis TN 38141-8310
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For Additional Information Contact | David Snyder 978-749-1440 |
Manufacturer Reason for Recall | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label. |
FDA Determined Cause 2 | Packaging change control |
Action | Smith & Nephew issued an "Urgent Medical Device RECALL Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 Distributors, sales reps, and district offices were directed to notify their customers.
If you have any questions or concerns regarding this recall, please contact FieldActions@smith nephew.com. |
Quantity in Commerce | 5 units |
Distribution | US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada |
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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