FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: 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
- Recall number
- Z-1901-2024
- 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
- Status
- Open, Classified
- Initiated
- 2024-04-24
- Posted
- 2024-05-24
- Terminated
- not on file
- Reason
- Packaging contained the incorrect size of femoral head from what was displayed on the label.
- 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
- 23 packages
- Distribution
- International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
- Lot, serial or model codes
- REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
- 510(k) numbers
- K022958, K021673
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3005551626
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28