Z-1901-2024Class II

smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14...

Name: Z-1901-2024 smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14...
Creator: Smith & Nephew Inc
Published: 2024-04-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-04-24 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of 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 on 2024-04-24. FDA classified it as Class II and gives the reason as "Packaging contained the incorrect size of femoral head from what was displayed on the label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1901-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-24
Posted: 2024-05-24
Recalling firm: Smith & Nephew, Inc.
Product: 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
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Packaging contained the incorrect size of femoral head from what was displayed on the label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The 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 commerce: 23 packages
Distribution: International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Product codes and lots: REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1901-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1901-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

Product code LZO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)