FDA recall Z-0153-2026

Product

BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT

Reason for recall

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Distribution

US Domestic distribution to Texas and Michigan.

Key facts

Status

Ongoing

Initiation date

2025-09-09

Report date

2025-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Port Huron, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2026