Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Brand Name: Persona Revision

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR;

Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the

Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

Product incorrectly labelled.

X3 TRIATHLON CS INSERT NO 3 10 MM

Potential packaging breaches of inner blister and outer sterile blister.

X3 TRIATHLON CS INSERT NO 6 10 MM

Potential packaging breaches of inner blister and outer sterile blister.

X3 TRIATHLON CS INSERT NO 6 11 MM

Potential packaging breaches of inner blister and outer sterile blister.

X3 TRIATHLON CS INSERT NO 7 9 MM

Potential packaging breaches of inner blister and outer sterile blister.