Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

Exactech Vantage Ankle System, Catalog Numbers:

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

The tibial tray lock detail is oversized (larger than specification).

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

The tibial tray lock detail is oversized (larger than specification).

Vantage Total Ankle System including

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Integra Cadence Total Ankle System

Posterior tibial fractures have been reported.

Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile.

Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.

Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6

As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media

Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6

As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media