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U.S. Department of Health and Human Services

Class 2 Device Recall OXINIUM

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 Class 2 Device Recall OXINIUMsee related information
Date Initiated by FirmApril 24, 2024
Date PostedMay 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1901-2024
Recall Event ID 94555
510(K)NumberK021673 K022958 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Productsmith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Code Information REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
6409 E Holmes Rd
Memphis TN 38141-8310
For Additional Information ContactDavid Snyker
978-749-1440
Manufacturer Reason
for Recall		Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued letters on 4/24/2024 informing the consignees of the issue, the patient impact, risks to health, and the actions to be taken by the users. The actions included to locate and quarantine affected devices immediately and if they have been further distributed to other organizations, the consignee is requested to inform their consignees of this field action and provide a copy of the letter. A Customer Response form is to be completed and emailed or FAX'd back to the national Smith + Nephew agency/distributor. The product is to be returned to the national Smith + Nephew agency/distributor.
Quantity in Commerce23 packages
DistributionInternational distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZO
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