—#207564

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

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K021673, K022958
Affected lot / code info: REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.

Why it was recalled

Packaging contained the incorrect size of femoral head from what was displayed on the label.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 6409 E Holmes Rd, Memphis, Tennessee 38141-8310

Distribution

Distribution pattern: International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.

Timeline

Recall initiated: 2024-04-24
Posted by FDA: 2024-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207564. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.