Recall Z-1901-2024
Smith & Nephew Inc · initiated April 24, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
Reason for recall
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1901-2024
- Initiated
- April 24, 2024
- Posted by FDA
- May 24, 2024
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Quantity
- 23 packages
- Distribution
- International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
- Recalling firm
- Smith & Nephew Inc, Memphis, TN