Ossur

Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032.

Physical Medicine Devices

1

No

Nationwide

Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

Lot Number: 08060305

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS

Lot Number: 08060408

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS

Lot Number: 08060410

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S

US affected Serial Numbers (1) New units: 9056, 9062, 9063, 9088, 9089, 9090, 9092, 9094, 9095, 9096, 9097, 9099, 9100, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9127, 9129, 9130, 9159, 9160, 9162, 9163, 9166 and 9169.   (2) Repaired units: 5138, 5141, 6624 and 9098.

Physical Medicine Devices

1

No

Nationwide.

Ossur Total Knee Model Number 2100, external knee prosthesis.