Howmedica Osteonics Corp.

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Potential packaging breaches of inner blister and outer sterile blister.

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility