Recall Z-1901-2024 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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
| Date | May 24, 2024 (initiated Apr 24, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 23 packages |
| Distribution | International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom. |
| FDA record | Open on fda.gov |