smith&nephew OXINIUM Femoral Head 12/14 Taper, REF… recallZ-1901-2024 · Smith & Nephew Inc · initiated Apr 24, 2024
Class II Open, Classified All recalls posted in May 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1901-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 24, 2024
- Posted by the FDA
- May 24, 2024
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 23 packages
- Product code
- LZO
- FDA submissions
- K022958, K021673
- Distribution
- International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
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
Code information (models, lots, serial numbers)
REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
Other devices under the same FDA submission
33 devices cleared under K022958, K021673 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OXINIUM 71343600Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented81 reports
- OXINIUM 71343200Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented58 reports
- OXINIUM 71343604Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented53 reports
- OXINIUM 71343603Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented41 reports
- OXINIUM 71343204Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented38 reports
- OXINIUM 71342800Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented35 reports
- OXINIUM 71343608Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented33 reports
- OXINIUM 71342804Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented29 reports
- OXINIUM 71343203Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented28 reports
- OXINIUM 71343208Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented22 reports
- OXINIUM 71342808Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented15 reports
- OXINIUM 71342803Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented13 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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