DJO Surgical: Delta Ceramic Femoral Head — Class II medical device recall Z-2604-2023
Ongoing recall by Encore Medical, LP, reported 2023-09-27, distributed in AL, AZ, CA, CO, FL, IL, IN, KS…. Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may
| Recall number | Z-2604-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2023-08-04 |
| Classified | 2023-09-19 |
| Reported by FDA | 2023-09-27 |
| Distributed | AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA |
| Countries outside the US | AU, CO, DE, FR, GB, SE |
| Quantity | 10 |
| UPC / GTIN / UDI-DI | 00888912076210 |
| Lot numbers | 00888912076210/878B1171 |
| Model numbers | 400-03-443 |
Product
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Reason for recall
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2604-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.