BioPro, Inc.: BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 1300

Hazard

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.

Details from the source

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. Quantity: 147 total Lot/code info: Product ID/UDI-DI 13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296 All lots, all serial numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.