smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71
Summary
The FDA issued a Class II for smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Steril by Smith & Nephew Inc. Reason: Packaging contained the incorrect size of femoral head from what was displayed on the label..
Details
Source
Device Recall
External ID
Z-1901-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
Product Description
smith&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
Lot/Code Info: REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
Quantity Affected: 23 packages
Reason for Recall
Packaging contained the incorrect size of femoral head from what was displayed on the label.
Distribution
International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-24
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew Inc has 78 FDA actions in our database, including 34 recalls and 44 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smith & Nephew Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew Inc have FDA actions?
Smith & Nephew Inc has 78 FDA actions in our database, including 34 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1901-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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