Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

Brand Name: Klassic BiPolar Head

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.

BioPro Bipolar Head

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.

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem

The Bipolar assembly contains an oversized Retainer Ring.

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers:

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.